NDC Code(s) : 49967-970-01, 49967-970-02, 49967-970-03, 49967-970-04
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 Itch Relief Moisturizingpramoxine hydrochloride LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-970
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMOXINE HYDROCHLORIDE(UNII: 88AYB867L5)
(PRAMOXINE - UNII:068X84E056) 		PRAMOXINE HYDROCHLORIDE1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
CETYL ALCOHOL(UNII: 936JST6JCN)
STEARIC ACID(UNII: 4ELV7Z65AP)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
GLYCERIN(UNII: PDC6A3C0OX)
DIMETHICONE(UNII: 92RU3N3Y1O)
NIACINAMIDE(UNII: 25X51I8RD4)
CERAMIDE 3(UNII: 4370DF050B)
CERAMIDE 6 II(UNII: F1X8L2B00J)
CERAMIDE 1(UNII: 5THT33P7X7)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
XANTHAN GUM(UNII: TTV12P4NEE)
BEHENTRIMONIUM METHOSULFATE(UNII: 5SHP745C61)
POLYGLYCERYL-3 DIISOSTEARATE(UNII: 46P231IQV8)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
ALLANTOIN(UNII: 344S277G0Z)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
SODIUM LAUROYL LACTYLATE(UNII: 7243K85WFO)
ARGININE PYROGLUTAMATE(UNII: 808T94CEU6)
EDETATE DISODIUM(UNII: 7FLD91C86K)
POTASSIUM PHOSPHATE, MONOBASIC(UNII: 4J9FJ0HL51)
POTASSIUM PHOSPHATE, DIBASIC(UNII: CI71S98N1Z)
ZINC CITRATE(UNII: K72I3DEX9B)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
PHYTOSPHINGOSINE(UNII: GIN46U9Q2Q)
CHOLESTEROL(UNII: 97C5T2UQ7J)
MYRISTIC ACID(UNII: 0I3V7S25AW)
PALMITIC ACID(UNII: 2V16EO95H1)
HYALURONIC ACID(UNII: S270N0TRQY)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: F68VH75CJC)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49967-970-01237 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product17/08/2017
2NDC:49967-970-0215 in 1 TRAY 17/08/2017
229.6 mL in 1 BOTTLE Type 0: Not a Combination Product17/08/2017
3NDC:49967-970-03473 mL in 1 BOTTLE Type 0: Not a Combination Product17/08/2017
4NDC:49967-970-04562 mL in 1 BOTTLE Type 0: Not a Combination Product17/08/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M017 08/17/2017

LABELER - L'Oreal USA Products Inc(002136794)

Establishment
Name Address ID/FEI Business Operations
L'OREAL USA PRODUCTS, INC 624244349 manufacture(49967-970), pack(49967-970)

Establishment
Name Address ID/FEI Business Operations
L'Oreal USA, Inc. 960317444 manufacture(49967-970), pack(49967-970)

Establishment
Name Address ID/FEI Business Operations
Accupac, LLC 061595175 manufacture(49967-970)

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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