NDC Code(s) : 49967-701-01, 49967-701-02
Packager : L'Oreal USA Products Inc

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CeraVe Developed with Dermatologists Psoriasis MoisturizingSalicylic Acid CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-701
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)
UREA(UNII: 8W8T17847W)
GLYCERYL STEARATE SE(UNII: FCZ5MH785I)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
NIACINAMIDE(UNII: 25X51I8RD4)
POLIDOCANOL(UNII: 0AWH8BFG9A)
MEADOWFOAM SEED OIL(UNII: 412ZHA4T4Y)
PEG-100 STEARATE(UNII: YD01N1999R)
LEVANT COTTONSEED OIL(UNII: N5CFT140R8)
BEHENTRIMONIUM METHOSULFATE(UNII: 5SHP745C61)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
C12-13 ALKYL LACTATE(UNII: 9GLX7JL13M)
DIMETHICONE(UNII: 92RU3N3Y1O)
CERAMIDE 3(UNII: 4370DF050B)
CERAMIDE 6 II(UNII: F1X8L2B00J)
CERAMIDE 1(UNII: 5THT33P7X7)
PHYTOSPHINGOSINE(UNII: GIN46U9Q2Q)
CHOLESTEROL(UNII: 97C5T2UQ7J)
TOCOPHEROL(UNII: R0ZB2556P8)
HYDROXYACETOPHENONE(UNII: G1L3HT4CMH)
HYDROGENATED OLIVE OIL(UNII: 53839415GI)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
DISODIUM EDTA-COPPER(UNII: 6V475AX06U)
SODIUM LAUROYL LACTYLATE(UNII: 7243K85WFO)
XANTHAN GUM(UNII: TTV12P4NEE)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)(UNII: Z135WT9208)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49967-701-01227 g in 1 JAR Type 0: Not a Combination Product30/08/2017
2NDC:49967-701-025 g in 1 JAR Type 1: Convenience Kit of Co-Package30/08/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M032 08/30/2017

LABELER - L'Oreal USA Products Inc(002136794)

Establishment
Name Address ID/FEI Business Operations
Accupac, Inc. 071609663 manufacture(49967-701), pack(49967-701)

Establishment
Name Address ID/FEI Business Operations
L'OREAL USA PRODUCTS, INC 624244349 manufacture(49967-701), pack(49967-701)

PRINCIPAL DISPLAY PANEL

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