NDC Code(s) : 0363-0229-10
Packager : Walgreen Co.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acne TreatmentBenzoyl peroxide GEL
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0229
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE(UNII: W9WZN9A0GM)
(BENZOYL PEROXIDE - UNII:W9WZN9A0GM) 		BENZOYL PEROXIDE1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)(UNII: 59TL3WG5CO)
EDETATE DISODIUM(UNII: 7FLD91C86K)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LAURETH-4(UNII: 6HQ855798J)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0363-0229-101 in 1 PACKAGE 12/02/2011
128 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M006 12/02/2011

LABELER - Walgreen Co.(008965063)

REGISTRANT - Nice-Pak Products, LLC(119091520)

Establishment
Name Address ID/FEI Business Operations
Nice-Pak Products, LLC 119091514 manufacture(0363-0229)

PRINCIPAL DISPLAY PANEL

Walgreens

WALGREENS PHARMACIST RECOMMENDED

Compare to the active ingredient in Clean & Clear ®Persa-Gel ®10††

Maximum Strength

Acne Treatment Gel

10% benzoyl peroxide/acne medication

  • Dermatologist tested
  • Paraben free, alcohol free & fragrance free

NET WT 1 OZ (28 g)

Place acne medication where pimples start*

*See directions for full instructions for use.

Maximum Strength

Acne Treatment Gel

10% benzoyl peroxide/acne medication

NET WT 1 OZ (28 g)

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