NDC Code(s) : 54108-3700-1
Packager : derma e

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acne Deep Pore Cleansing WashSALICYLIC ACID GEL
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54108-3700
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID(UNII: O414PZ4LPZ)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		SALICYLIC ACID20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DISODIUM LAURETH SULFOSUCCINATE(UNII: D6DH1DTN7E)
COCAMIDOPROPYL HYDROXYSULTAINE(UNII: 62V75NI93W)
COCAMIDOPROPYLAMINE OXIDE(UNII: M4SL82J7HK)
PEG-150 DISTEARATE(UNII: 6F36Q0I0AC)
POLYSORBATE 20(UNII: 7T1F30V5YH)
TEA TREE OIL(UNII: VIF565UC2G)
GLYCERIN(UNII: PDC6A3C0OX)
LAVENDER OIL(UNII: ZBP1YXW0H8)
ROSEWOOD OIL(UNII: F2522O5L7B)
SALIX ALBA BARK(UNII: 205MXS71H7)
MATRICARIA CHAMOMILLA WHOLE(UNII: G0R4UBI2ZZ)
DECYL GLUCOSIDE(UNII: Z17H97EA6Y)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54108-3700-1175 mL in 1 BOTTLE TYPE 0: NOT A COMBINATION PRODUCT01/01/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH DRUG M006 01/01/2015

LABELER - derma e(148940450)

REGISTRANT - Topiderm, Inc.(049121643)

Establishment
Name Address ID/FEI Business Operations
Topiderm, Inc. 049121643 MANUFACTURE(54108-3700)

Establishment
Name Address ID/FEI Business Operations
Topix Pharmaceuticals, Inc. 117745066 PACK(54108-3700)

PRINCIPAL DISPLAY PANEL

ANTI-ACNE

100% VEGAN • GMO-FREE
ECO-ETHICAL
CRUELTY-FREE

DERMA•E

Acne Deep Pore
Cleansing Wash

Active Salicylic Acid
with Tea Tree Oil + Chamomile

6 FL OZ / 175 mL

PRINCIPAL DISPLAY PANEL - 175 mL Bottle Label