NDC Code(s) : 49967-601-01, 49967-601-02
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 CleanserSalicylic Acid LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-601
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)
GLYCERIN(UNII: PDC6A3C0OX)
CAPRYL/CAPRAMIDOPROPYL BETAINE(UNII: 231H3ZT9NE)
UREA(UNII: 8W8T17847W)
SODIUM C14-16 OLEFIN SULFONATE(UNII: O9W3D3YF5U)
SHEA BUTTER(UNII: K49155WL9Y)
POLIDOCANOL(UNII: 0AWH8BFG9A)
PEG-150 PENTAERYTHRITYL TETRASTEARATE(UNII: 8L4OOQ76AM)
SODIUM LACTATE(UNII: TU7HW0W0QT)
DIETHYLENE GLYCOL MONOETHYL ETHER(UNII: A1A1I8X02B)
NIACINAMIDE(UNII: 25X51I8RD4)
GLUCONOLACTONE(UNII: WQ29KQ9POT)
C12-13 ALKYL LACTATE(UNII: 9GLX7JL13M)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SACCHARIDE ISOMERATE(UNII: W8K377W98I)
LACTIC ACID(UNII: 33X04XA5AT)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SODIUM LAUROYL LACTYLATE(UNII: 7243K85WFO)
CERAMIDE 3(UNII: 4370DF050B)
CERAMIDE 6 II(UNII: F1X8L2B00J)
PHYTOSPHINGOSINE(UNII: GIN46U9Q2Q)
CHOLESTEROL(UNII: 97C5T2UQ7J)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
XANTHAN GUM(UNII: TTV12P4NEE)
CARBOXYPOLYMETHYLENE(UNII: 0A5MM307FC)
CERAMIDE 1(UNII: 5THT33P7X7)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49967-601-01237 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product18/08/2017
2NDC:49967-601-0228 mL in 1 BOTTLE Type 1: Convenience Kit of Co-Package18/08/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M032 08/18/2017 08/31/2025

LABELER - L'Oreal USA Products Inc(002136794)

Establishment
Name Address ID/FEI Business Operations
Accupac, Inc. 071609663 manufacture(49967-601)

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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