NDC Code(s) : 49967-512-01, 49967-512-02, 49967-512-03
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 CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-512
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMOXINE HYDROCHLORIDE(UNII: 88AYB867L5)
(PRAMOXINE - UNII:068X84E056) 		PRAMOXINE HYDROCHLORIDE10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
PETROLATUM(UNII: 4T6H12BN9U)
CETYL ALCOHOL(UNII: 936JST6JCN)
STEARIC ACID(UNII: 4ELV7Z65AP)
SHEA BUTTER(UNII: K49155WL9Y)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
DIMETHICONE(UNII: 92RU3N3Y1O)
PALMITIC ACID(UNII: 2V16EO95H1)
MYRISTIC ACID(UNII: 0I3V7S25AW)
CERAMIDE 3(UNII: 4370DF050B)
CERAMIDE 6 II(UNII: F1X8L2B00J)
CERAMIDE 1(UNII: 5THT33P7X7)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
BEHENTRIMONIUM METHOSULFATE(UNII: 5SHP745C61)
XANTHAN GUM(UNII: TTV12P4NEE)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
ALCOHOL(UNII: 3K9958V90M)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
SODIUM LAUROYL LACTYLATE(UNII: 7243K85WFO)
EDETATE DISODIUM(UNII: 7FLD91C86K)
POTASSIUM PHOSPHATE, MONOBASIC(UNII: 4J9FJ0HL51)
POTASSIUM PHOSPHATE, DIBASIC(UNII: CI71S98N1Z)
TASMANNIA LANCEOLATA FRUIT(UNII: PNT2HDL13Q)
PHYTOSPHINGOSINE(UNII: GIN46U9Q2Q)
CHOLESTEROL(UNII: 97C5T2UQ7J)
HYALURONIC ACID(UNII: S270N0TRQY)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: F68VH75CJC)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49967-512-01340 g in 1 JAR Type 0: Not a Combination Product18/09/2017
2NDC:49967-512-02453.6 g in 1 JAR Type 0: Not a Combination Product18/09/2017
3NDC:49967-512-03538.6 g in 1 JAR Type 0: Not a Combination Product18/09/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M017 09/18/2017

LABELER - L'Oreal USA Products Inc(002136794)

Establishment
Name Address ID/FEI Business Operations
Accupac, Inc. 071609663 MANUFACTURE(49967-512)

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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