NDC Code(s) : 49967-108-01, 49967-108-02
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 Anti ItchHydrocortisone CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-108
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE(UNII: WI4X0X7BPJ)
(HYDROCORTISONE - UNII:WI4X0X7BPJ) 		HYDROCORTISONE10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER(UNII: YRC528SWUY)
GLYCERIN(UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BENZYL ALCOHOL(UNII: LKG8494WBH)
CETYL PALMITATE(UNII: 5ZA2S6B08X)
ISOSTEARYL NEOPENTANOATE(UNII: 411THY156Q)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
POTASSIUM LACTATE(UNII: 87V1KMK4QV)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
DEANOL(UNII: 2N6K9DRA24)
PEG-40 STEARATE(UNII: ECU18C66Q7)
METHYLPARABEN(UNII: A2I8C7HI9T)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
NIACINAMIDE(UNII: 25X51I8RD4)
OAT(UNII: Z6J799EAJK)
SODIUM LAUROYL LACTYLATE(UNII: 7243K85WFO)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
SODIUM BENZOATE(UNII: OJ245FE5EU)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
TANACETUM PARTHENIUM(UNII: 6GE7Z0761K)
CERAMIDE 3(UNII: 4370DF050B)
CERAMIDE 6 II(UNII: F1X8L2B00J)
PHYTOSPHINGOSINE(UNII: GIN46U9Q2Q)
CHOLESTEROL(UNII: 97C5T2UQ7J)
XANTHAN GUM(UNII: TTV12P4NEE)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
CERAMIDE 1(UNII: 5THT33P7X7)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49967-108-011 in 1 CARTON 14/11/2017
128 g in 1 TUBE Type 0: Not a Combination Product
2NDC:49967-108-0214 g in 1 TUBE Type 0: Not a Combination Product14/11/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M017 11/14/2017

LABELER - L'Oreal USA Products Inc.(002136794)

Establishment
Name Address ID/FEI Business Operations
Accupac, Inc 071609663 MANUFACTURE(49967-108)

PRINCIPAL DISPLAY PANEL

image of a carton

image of a carton