NDC Code 49967-970-02 | pharmacompass.com

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

CeraVe Developed with Dermatologists Itch Relief Moisturizingpramoxine hydrochloride LOTION

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PRAMOXINE HYDROCHLORIDE(UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49967-970-01	237 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product	17/08/2017
2	NDC:49967-970-02	15 in 1 TRAY	17/08/2017
2		29.6 mL in 1 BOTTLE Type 0: Not a Combination Product	17/08/2017
3	NDC:49967-970-03	473 mL in 1 BOTTLE Type 0: Not a Combination Product	17/08/2017
4	NDC:49967-970-04	562 mL in 1 BOTTLE Type 0: Not a Combination Product	17/08/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	08/17/2017

LABELER - L'Oreal USA Products Inc(002136794)

NDC 49967-970-02
API & Excipient Details