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DRUG PRODUCT COMPOSITIONS0
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1. Benzoyl Superoxide
2. Dibenzoyl Peroxide
3. Diphenylglyoxal Superoxide
4. Panoxyl
5. Peroxide, Benzoyl
6. Peroxide, Dibenzoyl
7. Superoxide, Benzoyl
8. Superoxide, Diphenylglyoxal
1. 94-36-0
2. Peroxide, Dibenzoyl
3. Dibenzoyl Peroxide
4. Benzoyl Superoxide
5. Benzoperoxide
6. Acetoxyl
7. Benoxyl
8. Lucidol
9. Panoxyl
10. Benzol Peroxide
11. Dibenzoylperoxid
12. Benzoylperoxid
13. Asidopan
14. Persadox
15. Benzac
16. Eloxyl
17. Mytolac
18. Oxylite
19. Diphenylglyoxal Peroxide
20. Resdan Akne
21. Epi-clear
22. Persa-gel
23. Akneroxid 5
24. Dry And Clear
25. Duresthin 5
26. Benzoyl Benzenecarboperoxoate
27. Luperco Ast
28. Nayper Bo
29. Benzoylperoxyde
30. Loroxide
31. Theraderm
32. Dibenzoylperoxyde
33. Peroxyde De Benzoyle
34. Lucidol B 50
35. Lucidol G 20
36. Perossido Di Benzoile
37. Benzoylperoxide
38. Benzoic Acid, Peroxide
39. Acnegel
40. Benzaknen
41. Brevoxyl
42. Debroxide
43. Desanden
44. Incidol
45. Novadelox
46. Vanoxide
47. Garox
48. Topex
49. Xerac
50. Luperox Fl
51. Akneroxide L
52. Cadox Bs
53. Quinolor Compound
54. Desquam E
55. Benzac W
56. Clear By Design
57. Luperco Aa
58. Cadox B
59. Nayper B And Bo
60. Aztec Bpo
61. Benzagel 10
62. Lucidol (peroxide)
63. Benzagel
64. Benzashave
65. Cadox 40e
66. Norox Bzp-250
67. Norox Bzp-c-35
68. Desquam X
69. Desquam-x
70. Acne-aid Cream
71. Benbel C
72. Cadat Bpo
73. Lucidol-70
74. Aksil 5
75. Lucidol 50p
76. Lucidol Kl 50
77. Oxy-10 Cover
78. Superox 744
79. Chaloxyd Bp 50ft
80. Abcat 40
81. Benox 50
82. Diphenylperoxyanhydride
83. Benzoic Peroxyanhydride
84. Cadox B 40e
85. Cadox B 50p
86. Cadox B 70w
87. Oxy 5
88. Oxy-5
89. Cadox B-ch 50
90. Fostex Bpo
91. Phisoac Bp
92. Xerac Bp
93. Benzoyl Peroxide [usan]
94. Benoxyl (5&10) Lotion
95. Epi Clear Antiseptic Lotion
96. Stri-dex B.p.
97. Peroxyderm
98. Benzaknew
99. Benzoyl
100. Bzf-60
101. Dermoxyl
102. Luzidol
103. Nericur
104. Oxy-10
105. Peroxydex
106. Preoxydex
107. Sanoxit
108. Superox
109. Benzoylperoxid [german]
110. Cadet
111. Benzoyl-peroxide
112. Dibenzoylperoxide
113. Benzoyl Peroxyde
114. Akneroxid L
115. Dibenzoylperoxid [german]
116. Clearasil Antibacterial Acne Lotion
117. Lucidol 75fp
118. Oxy-l
119. Component Of Oxy-5
120. Component Of Vanoxide
121. Xerac Bp 5
122. Bpo
123. Oxy Wash
124. Xerac Bp 10
125. Nsc-671
126. Nsc-675
127. Ins No.928
128. Abcure S-40-25
129. Anhydrous Benzoyl Peroxide
130. Benzoyl Peroxide Anhydrous
131. W9wzn9a0gm
132. Clearasil Bp Acne Treatment
133. Ins-928
134. Nsc671
135. Chebi:82405
136. Clearasil Benzoyl Peroxide Lotion
137. Nsc 675
138. Ncgc00159380-02
139. Ncgc00159380-05
140. Benzoylperoxid (german)
141. Wln: Rvoovr
142. Benzoyl Peroxide (usan)
143. Dibenzoylperoxid (german)
144. E-928
145. Dsstox_cid_1072
146. Novadelox (18% Benzoyl Peroxide, 78% Calcium Sulphate, 4% Magnesium Carbonate)
147. Dsstox_rid_77460
148. Dsstox_gsid_24591
149. Benprox
150. Benzefoam
151. Lavoclen
152. Benzoylperoxyde [dutch]
153. Pacnex
154. Neobenz Micro
155. Dibenzoylperoxyde [dutch]
156. Peroxide, Benzoyl
157. Cas-94-36-0
158. Ccris 630
159. Stri-dex B.p
160. Superoxide, Benzoyl
161. Benzoyl Peroxide Gel
162. Peroxyde De Benzoyle [french]
163. Hsdb 372
164. Perossido Di Benzoile [italian]
165. Nsc 671
166. B 75w
167. Clearasil Bp Acne Treatment Cream
168. Diphenylglyoxal Superoxide
169. Einecs 202-327-6
170. Unii-w9wzn9a0gm
171. Superoxide, Diphenylglyoxal
172. Thermaderm
173. G 20
174. Lucilite
175. Lucipal
176. Novadeiox
177. Periygel
178. Peroxyl
179. Presadox
180. Bezoyl Peroxide
181. Florox
182. Benzoyl Peroide
183. Bepio
184. Silica Hydrogel
185. Triaz
186. Benzoyl Peroxide [usan:usp]
187. Luperco A
188. Di-benzoylperoxide
189. Dibenzoy Lperoxide
190. Dibenzoyl Peroxyde
191. Dibenzoyl-peroxide
192. Lucidol Gs
193. Lucidol Rm
194. Luperco Ac
195. Luperco Afr
196. Bzoobz
197. Nyper B
198. Bis Benzoylperoxide
199. Bisbenzoyl Peroxide
200. Cadox Bta
201. Nyper Bmt
202. Di-benzoyl Peroxide
203. Perkadox 20s
204. Cuticura Acne Cream
205. Lucidol 70
206. Lucidol 78
207. Lucidol-78
208. Luperox A98
209. Mfcd00003071
210. Bbpo
211. Epsolay
212. Bepio (tn)
213. Benzagel (salt/mix)
214. Benzoyl Dioxide
215. Luperco Afr-250
216. Sulfoxyl (salt/mix)
217. Cadet Bpo 78w
218. Cadet Bpo-70w
219. Cadox Bpo-w40
220. Cadox Btw-50
221. Benzoyl Peroxide(usan)
222. Benzoyl Peroxide [1]
223. Benzoyl Peroxide [2]
224. Benzoyl Peroxide [3]
225. Benzoyl Peroxide [4]
226. Benzoyl Peroxide [5]
227. Benzoyl Peroxide [6]
228. Benzoyl Peroxide [7]
229. Benzoyl Peroxide [8]
230. Benzoyl Peroxide [9]
231. Hydrous Benzoyl Peroxide
232. Benzoyl Peroxide, Usan
233. Xerac Bp (salt/mix)
234. Acetoxyl 2.5 And 5
235. Benzoyl Peroxide (usp)
236. Diphenylperoxyanhydride #
237. Schembl63
238. Triaz;dibenzoyl Peroxide
239. Fostex Bpo (salt/mix)
240. Aztec Benzoyl Peroxide-dry
241. Ec 202-327-6
242. Benzoylis Peroxidum Cum Aqua
243. Benzoyl Peroxide (jan/usp)
244. Mls000028899
245. Benzoyl Peroxide [mi]
246. Bidd:gt0840
247. Benzoyl Peroxide (wet)
248. Benzoyl Peroxide [fcc]
249. Benzoyl Peroxide [jan]
250. Aztec Benzoyl Peroxide-70-77
251. Nsc675
252. Zinc1016
253. Benzoyl Peroxide [hsdb]
254. Benzoyl Peroxide [iarc]
255. Benzoyl Peroxide [inci]
256. Benzoyl Peroxide [vandf]
257. Chembl1200370
258. Dtxsid6024591
259. Benzoyl Peroxide [mart.]
260. Benzoyl Peroxide, Remainder Water
261. Fostex Bpo Bar, Gel, And Wash
262. Benzoyl Peroxide [who-dd]
263. Component Of Vanoxide (salt/mix)
264. Hms2092f22
265. Pharmakon1600-01503004
266. Phenylcarbonyl Benzenecarboperoxoate
267. Na 2085 (dot)
268. Un 2085 (dot)
269. Idp-126 Component Benzoyl Peroxide
270. Tox21_111619
271. Benzoyl Peroxide (luperox(r) A75)
272. Benzoyl Peroxide (luperox(r) A98)
273. Br1012
274. Nsc758205
275. Benzoyl Peroxide (luperox(r) A70s)
276. Akos000120600
277. Benzenecarboperoxoic Acid Benzoyl Ester
278. Benzoyl Peroxide [orange Book]
279. Duac Component Benzoyl Peroxide
280. Tox21_111619_1
281. Benzoyl Peroxide (luperox(r) A75fp)
282. Benzoyl Peroxide [usp Impurity]
283. Ccg-213090
284. Db09096
285. Nsc-758205
286. Sc10147
287. Un 2086
288. Un 2088
289. Acanya Component Benzoyl Peroxide
290. Epiduo Component Benzoyl Peroxide
291. Twyneo Component Benzoyl Peroxide
292. Ncgc00159380-03
293. Ncgc00159380-04
294. 2685-64-5
295. Benzoyl Peroxide Component Of Duac
296. Bp-21236
297. E928
298. Hydrous Benzoyl Peroxide [who-ip]
299. Smr000058568
300. W 75
301. Benzaclin Component Benzoyl Peroxide
302. Sbi-0206719.p001
303. Benzamycin Component Benzoyl Peroxide
304. Benzoyl Peroxide Component Of Acanya
305. Benzoyl Peroxide Component Of Epiduo
306. Benzoyl Peroxide Component Of Twyneo
307. Db-022598
308. B3152
309. Benzoyl Peroxide, Blend In Dibutyl Phthalate
310. Benzoyl Peroxide Component Of Benzaclin
311. Benzoyl Peroxide, Blend In Tricresyl Phosphate
312. Benzoyl Peroxide Component Of Benzamycin
313. C19346
314. D03093
315. Ab01562988_01
316. Benzoyl Peroxide, For Synthesis, 72.0-80.0%
317. Hydrous Benzoyl Peroxide [usp Monograph]
318. Mixture Of Dibenzoyl Peroxide And Calcium Sulfate
319. A844933
320. Mixture Of Dibenzoyl Peroxide And Calcium Sulphate
321. Q411424
322. Sr-05000001817
323. Benzoylis Peroxidum Cum Aqua [who-ip Latin]
324. Sr-05000001817-1
325. Brd-k59986511-001-02-3
326. Benzoyl Peroxide, 97% (dry Wt.), Wet With 25% Water
327. Benzoyl Peroxide, Saj First Grade, >=98.0% Dry Basis
328. F0001-2260
329. Luperox(r) A75, Benzoyl Peroxide 75%, Remainder Water
330. Luperox(r) A70s, Benzoyl Peroxide, 70%, Remainder Water
331. Luperox(r) A75, Benzoyl Peroxide, 75%, Remainder Water
332. Luperox(r) A98, Benzoyl Peroxide, Reagent Grade, >=98%
333. Benzoyl Peroxide Blend With Dicyclohexyl Phthalate, Technical, ~50% (t)
334. Luperox(r) Atc50, Benzoyl Peroxide, ~50 Wt. % In Tricresyl Phosphate
335. Luperox(r) Afr40, Benzoyl Peroxide Solution, 40 Wt. % In Dibutyl Phthalate
336. Benzoyl Peroxide Blend With Dicyclohexyl Phthalate, Suitable For Use As A Catalyst For Electron Microscopy. Modified To Render It Safe In Transit.
337. Luperox(r) A75fp, Benzoyl Peroxide, 75% Remainder Water, Contains 25 Wt. % Water As Stabilizer, 75%
| Molecular Weight | 242.23 g/mol |
|---|---|
| Molecular Formula | C14H10O4 |
| XLogP3 | 3.5 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 5 |
| Exact Mass | 242.05790880 g/mol |
| Monoisotopic Mass | 242.05790880 g/mol |
| Topological Polar Surface Area | 52.6 Ų |
| Heavy Atom Count | 18 |
| Formal Charge | 0 |
| Complexity | 258 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
MEDICATION (VET): Keratolytic.
O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. Cambridge, UK: Royal Society of Chemistry, 2013., p. 197
Its principal use is in the treatment of mild acne vulgaris (in which it is comedolytic) and acne rosacea, but it also is used in the treatment of decubital and stasis ulcers.
Troy, D.B. (Ed); Remmington The Science and Practice of Pharmacy. 21 st Edition. Lippincott Williams & Williams, Philadelphia, PA 2005, p. 1288
Three multicenter, randomized, double blind, parallel-group, placebo controlled studies involving 3,855 subjects established the safety and efficacy of an adapalene benzoyl peroxide topical gel in the treatment of acne for all skin types. The data from these 3 studies were pooled and the subgroup of self-identified black subjects was analyzed separately. Significantly more black subjects had IGA success with adapalene-BPO than with vehicle at week 12. Significantly more black subjects also had decreased total, inflammatory, and noninflammatory lesion counts with adapalene-BPO that were seen as early as week 1. Adapalene-BPO was well tolerated in the black subjects included in this analysis and no cases of treatment-related PIH were observed. Similar results were obtained for this subgroup as the overall population from the 3 studies. Based on the results from this analysis, adapalene-BPO is a safe and effective treatment for acne in black skin. /Adapalene-BPO/
PMID:24509968 Alexis AF et al; J Drugs Dermatol 13 (2): 170-4 (2014)
/The study objective was to/ compare the safety and efficacy of 1% and 5% silica encapsulated benzoyl peroxide (E-BPO) in patients with papulopustular rosacea. /This was a/ multi-centered randomized, double blind, vehicle controlled parallel group, 12 week treatment in 92 patients with papulopustular rosacea. Primary endpoints were dichotomized IGA with success defined as clear/near clear and reduction in inflammatory lesions. /The study included/ 92 patients: 74% graded as moderate IGA, 14% severe and 12% mild. The mean inflammatory lesion count was 24. /The intervention was/ once daily treatment for 12 weeks with vehicle, 1% or 5% E-BPO. 1% and 5% E-BPO were superior to vehicle in reducing papulopustular lesions P =0.01 and P =0.02. 5% E-BPO was superior to vehicle for IGA P =0.0013.
PMID:24918558 Leyden JJ; J Drugs Dermatol 13 (6): 685-8 (2014)
For more Therapeutic Uses (Complete) data for Dibenzoyl peroxide (11 total), please visit the HSDB record page.
Benzoyl peroxide should not be applied under an occlusive dressing, because it is a potent experimental contact sensitizer (delayed hypersensitivity). ... When hypersensitivity is suspected, patch tests may be performed with a freshly prepared 5% concentration in petrolatum or diluted commercial product.
American Medical Association, Council on Drugs. AMA Drug Evaluations Annual 1994. Chicago, IL: American Medical Association, 1994., p. 1201
Contact hypersensitivity is observed in 1% to 3% of patients under conditions of recommended use.
American Medical Association, Council on Drugs. AMA Drug Evaluations Annual 1994. Chicago, IL: American Medical Association, 1994., p. 1201
3. 3= Moderately toxic: Probable oral lethal dose (human) 0.5-5 g/kg, between 1 oz and 1 pint (or 1 lb) for 70 kg person (150 lb).
Gosselin, R.E., H.C. Hodge, R.P. Smith, and M.N. Gleason. Clinical Toxicology of Commercial Products. 4th ed. Baltimore: Williams and Wilkins, 1976., p. II-75
Benzoyl peroxide is formulated with antibiotics such as [erythromycin] and [clindamycin] for the treatment of acne vulgaris. Benzoyl peroxide is formulated as a number of topical products for the treatment of acne. Benzoyl peroxide is also indicated in combination with [tretinoin] for the treatment of acne vulgaris in patients aged nine years and older.
Benzoyl peroxide is a topical treatment for acne that generates free radicals to break down comedones and increase the rate of epithelial cell turnover. It has a short duration of action as its active free radical metabolites quickly react to form inactive metabolites. The therapeutic index is wide, as overdoses are rare, however patients may still experience skin peeling. Patients should be counselled regarding increased risks of skin irritation, dryness, and sunburn.
Dermatologic Agents
Drugs used to treat or prevent skin disorders or for the routine care of skin. (See all compounds classified as Dermatologic Agents.)
D10AE01
S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355
D - Dermatologicals
D10 - Anti-acne preparations
D10A - Anti-acne preparations for topical use
D10AE - Peroxides
D10AE01 - Benzoyl peroxide
Absorption
In a sample of excised skin, 1.9% of a radiolabelled topical dose fully penetrates the skin, and 2.6% remains in the skin. The radiolabelled dose that fully penetrates the skin is recovered as benzoic acid, while the dose in the skin is approximately half benzoic acid and half benzoyl peroxide. 95.5% of a radiolabelled dose is not absorbed or metabolized after 8 hours.
Route of Elimination
Benzoyl peroxide's metabolite benzoic acid, is eliminated in the urine. Data regarding fecal elimination is not readily available.
Approximately one-half of a dose of benzoyl peroxide is absorbed to some extent after topical application to the forearm of primates ... .
American Medical Association, Council on Drugs. AMA Drug Evaluations Annual 1994. Chicago, IL: American Medical Association, 1994., p. 1201
Skin absorption of benzoyl peroxide from a topical lotion containing freely dispersed drug was compared with that from the same lotion in which the drug was entrapped in a controlled-release styrene-divinylbenzene polymer system. In an in vitro diffusion system, statistically significant (p = 0.01) differences were found in the content of benzoyl peroxide in excised human skin and in percutaneous absorption. In vivo, significantly (p = 0.002) less benzoyl peroxide was absorbed through rhesus monkey skin from the polymeric system. This controlled release of benzoyl peroxide to skin can alter the dose relation that exists between efficacy and skin irritation. Corresponding studies showed reduced skin irritation in cumulative irritancy studies in rabbits and human beings, whereas in vivo human antimicrobial efficacy studies showed that application of the formulations containing entrapped benzoyl peroxide significantly reduced counts of Propionibacterium acnes (p less than 0.001) and aerobic bacteria (p less than 0.001) and the free fatty acid/triglyceride ratio in skin lipids. These findings support the hypothesis that, at least for this drug, controlled topical delivery can enhance safety without sacrificing efficacy.
PMID:1869643 Wester RC et al; J Am Acad Dermatol 24 (5 Pt 1): 720-6 (1991)
The transepidermal penetration and metabolic disposition of (14)C-benzoyl peroxide were assessed in vitro (excised human skin) and in vivo (rhesus monkey). In vitro, the benzoyl peroxide penetrated into the skin, through the stratum corneum or the follicular openings, or both, and was recovered on the dermal side as benzoic acid. In vivo, benzoic acid was recovered from urine in amounts equivalent to 45% and 98% of the radiolabel following, respectively, topical and intramuscular administration of small amounts of (14)C-benzoyl peroxide. We conclude that benzoyl peroxide penetrates as such into the skin layers and is converted therein to benzoic acid, which, in turn is absorbed into the systemic circulation. Renal clearance of the metabolite is sufficiently rapid as to preclude its hepatic conjugation with glycine, since following topical administration to rhesus monkeys, no hippuric acid was found in the urine, as could have been expected had a significant amount of benzoic acid passed through the liver.
PMID:7204686 Nacht S et al; J Am Acad Dermatol 4 (1): 31-7 (1981)
The percutaneous penetration and the metabolism of benzoyl peroxide (BPO) were assessed in vitro on human skin and in vivo on 5 patients with leg ulcers. The BPO in vitro absorbed by the skin was converted to benzoic acid preferably in the dermis. The portion penetrated through the skin was benzoic acid only. Also in patients treated with BPO, no BPO could be detected in the serum. These findings show that BPO as such is absorbed by the skin, but is systemically absorbed only after the metabolization to benzoic acid. Therefore a systemic-toxic effect in local therapy with BPO can be excluded.
PMID:7200789 Morsches B, Holzmann H; Arzneimittelforsch 32 (3): 298-300 (1982)
For more Absorption, Distribution and Excretion (Complete) data for Dibenzoyl peroxide (7 total), please visit the HSDB record page.
The peroxide bond of benzoyl peroxide is cleaved to form 2 benzoyloxy radicals. The benzyoyloxy radicals may interact with other molecules, forming benzoic acid; alternatively, benzoyloxy radicals can break down further to release carbon dioxide and a phenyl radical.
Benzoic acid is a major metabolite.
American Medical Association, Council on Drugs. AMA Drug Evaluations Annual 1994. Chicago, IL: American Medical Association, 1994., p. 1201
The transepidermal penetration and metabolic disposition of (14)C-benzoyl peroxide were assessed in vitro (excised human skin) and in vivo (rhesus monkey). In vitro, the benzoyl peroxide penetrated into the skin, through the stratum corneum or the follicular openings, or both, and was recovered on the dermal side as benzoic acid. In vivo, benzoic acid was recovered from urine in amounts equivalent to 45% and 98% of the radiolabel following, respectively, topical and intramuscular administration of small amounts of (14)C-benzoyl peroxide. We conclude that benzoyl peroxide penetrates as such into the skin layers and is converted therein to benzoic acid, which, in turn is absorbed into the systemic circulation. Renal clearance of the metabolite is sufficiently rapid as to preclude its hepatic conjugation with glycine, since following topical administration to rhesus monkeys, no hippuric acid was found in the urine, as could have been expected had a significant amount of benzoic acid passed through the liver.
PMID:7204686 Nacht S et al; J Am Acad Dermatol 4 (1): 31-7 (1981)
Benzoyl peroxide (BzPO) is both a tumor promoter and progressor in mouse skin; however, BzPO is neither an initiator nor a complete carcinogen in this tissue. Although not mutagenic, BzPO has been observed to produce strand breaks in DNA of exposed cells. These actions are presumed to be mediated by free-radical derivatives of BzPO. Previous studies suggested that the metabolism of BzPO in keratinocytes proceeds via the initial cleavage of the peroxide bond, yielding benzoyloxy radicals which, in turn, can either fragment to form phenyl radicals and carbon dioxide or abstract H atoms from biomolecules to yield benzoic acid. Benzoic acid is the major stable metabolite of BzPO produced by keratinocytes. In the present study we have investigated the role of BzPO and its metabolites in the generation of strand scissions in a cell-free system using phi X-174 plasmid DNA. In this system BzPO produced DNA damage that was dose-dependent over a concentration range of 0.1-1 mM and required the presence of copper but not other transition metals. By contrast, benoic acid did not produce DNA damage in this system, either in the presence or in the absence of copper. The inclusion of spin trapping agents, such as N-tert-butyl-alpha-phenylnitrone (PBN), 3,5-dibromo-4-nitrosobenzenesulfonate, and nitrosobenzene, in incubations was found to significantly reduce the extent of DNA damage generated via the copper-mediated activation of BzPO. Electron paramagnetic resonance spectroscopy studies suggested that the primary radical trapped by PBN following copper-mediated decomposition of BzPO was the benzoyloxy radical.
PMID:1782351 Swauger JE et al; Chem Res Toxicol 4 (2): 223-8 (1991)
No reports found; [TDR, p. 174]
TDR - Ryan RP, Terry CE, Leffingwell SS (eds). Toxicology Desk Reference: The Toxic Exposure and Medical Monitoring Index, 5th Ed. Washington DC: Taylor & Francis, 1999., p. 174
Acne vulgaris is caused by inflammation in the pilosebaceous gland. Acne is generally caused by increased excretion of sebum from pilosebaceous glands, endocrine factors such as androgenic hormones, keratin developing around follicles, bacterial growth, and inflammation. These factors contribute to the formation of comedones (whiteheads and blackheads). The peroxide bond of benzoyl peroxide is cleaved to form 2 benzoyloxy radicals. These radicals interact nonspecifically with bacterial proteins, interfering with their function, and survival of the bacteria. Over time, free radical interactions with bacterial proteins lead to decreased keratin and sebum around follicles. Benzoyl peroxide can also increase the turnover rate of epithelial cells, leading to skin peeling, and breaking down comedones.
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DOSAGE - GEL;TOPICAL - 5%;3%
USFDA APPLICATION NUMBER - 50557
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USFDA APPLICATION NUMBER - 50741
DOSAGE - GEL;TOPICAL - 5%;EQ 1% BASE
USFDA APPLICATION NUMBER - 50756
DOSAGE - GEL;TOPICAL - 5%;3%
USFDA APPLICATION NUMBER - 50769
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ABOUT THIS PAGE
36
PharmaCompass offers a list of Benzoyl Peroxide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Benzoyl Peroxide manufacturer or Benzoyl Peroxide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Benzoyl Peroxide manufacturer or Benzoyl Peroxide supplier.
PharmaCompass also assists you with knowing the Benzoyl Peroxide API Price utilized in the formulation of products. Benzoyl Peroxide API Price is not always fixed or binding as the Benzoyl Peroxide Price is obtained through a variety of data sources. The Benzoyl Peroxide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Topex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Topex, including repackagers and relabelers. The FDA regulates Topex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Topex API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Topex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Topex supplier is an individual or a company that provides Topex active pharmaceutical ingredient (API) or Topex finished formulations upon request. The Topex suppliers may include Topex API manufacturers, exporters, distributors and traders.
click here to find a list of Topex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Topex DMF (Drug Master File) is a document detailing the whole manufacturing process of Topex active pharmaceutical ingredient (API) in detail. Different forms of Topex DMFs exist exist since differing nations have different regulations, such as Topex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Topex DMF submitted to regulatory agencies in the US is known as a USDMF. Topex USDMF includes data on Topex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Topex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Topex suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Topex Drug Master File in Korea (Topex KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Topex. The MFDS reviews the Topex KDMF as part of the drug registration process and uses the information provided in the Topex KDMF to evaluate the safety and efficacy of the drug.
After submitting a Topex KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Topex API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Topex suppliers with KDMF on PharmaCompass.
A Topex CEP of the European Pharmacopoeia monograph is often referred to as a Topex Certificate of Suitability (COS). The purpose of a Topex CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Topex EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Topex to their clients by showing that a Topex CEP has been issued for it. The manufacturer submits a Topex CEP (COS) as part of the market authorization procedure, and it takes on the role of a Topex CEP holder for the record. Additionally, the data presented in the Topex CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Topex DMF.
A Topex CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Topex CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Topex suppliers with CEP (COS) on PharmaCompass.
A Topex written confirmation (Topex WC) is an official document issued by a regulatory agency to a Topex manufacturer, verifying that the manufacturing facility of a Topex active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Topex APIs or Topex finished pharmaceutical products to another nation, regulatory agencies frequently require a Topex WC (written confirmation) as part of the regulatory process.
click here to find a list of Topex suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Topex as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Topex API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Topex as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Topex and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Topex NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Topex suppliers with NDC on PharmaCompass.
Topex Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Topex GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Topex GMP manufacturer or Topex GMP API supplier for your needs.
A Topex CoA (Certificate of Analysis) is a formal document that attests to Topex's compliance with Topex specifications and serves as a tool for batch-level quality control.
Topex CoA mostly includes findings from lab analyses of a specific batch. For each Topex CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Topex may be tested according to a variety of international standards, such as European Pharmacopoeia (Topex EP), Topex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Topex USP).
