NDC Code(s) : 54108-3750-1
Packager : derma e

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Deep Pore Acne ScrubSALICYLIC ACID PASTE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54108-3750
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 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
PRUNUS ARMENIACA SEED(UNII: 75356789IW)
CETYL ALCOHOL(UNII: 936JST6JCN)
GLYCERYL STEARATE CITRATE(UNII: WH8T92A065)
HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN(UNII: 9F8ET54T05)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
GLYCERIN(UNII: PDC6A3C0OX)
STEARIC ACID(UNII: 4ELV7Z65AP)
DECYL GLUCOSIDE(UNII: Z17H97EA6Y)
TEA TREE OIL(UNII: VIF565UC2G)
LAVENDER OIL(UNII: ZBP1YXW0H8)
ALLANTOIN(UNII: 344S277G0Z)
SALIX ALBA BARK(UNII: 205MXS71H7)
ROSEWOOD OIL(UNII: F2522O5L7B)
JOJOBA OIL(UNII: 724GKU717M)
MATRICARIA CHAMOMILLA WHOLE(UNII: G0R4UBI2ZZ)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
XANTHAN GUM(UNII: TTV12P4NEE)
POLYSORBATE 20(UNII: 7T1F30V5YH)
POLYSORBATE 60(UNII: CAL22UVI4M)
GLYCERYL STEARATE SE(UNII: FCZ5MH785I)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54108-3750-1113 g in 1 TUBE 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(54108-3750)

PRINCIPAL DISPLAY PANEL

ANTI-ACNE

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

DERMA•E

Deep Pore
Acne Scrub

Active Salicylic Acid
with Tea Tree Oil + Aloe Vera

4 OZ / 113 g

PRINCIPAL DISPLAY PANEL - 113 g Tube Label