NDC Code(s) : 49967-500-01, 49967-500-02, 49967-500-03, 49967-500-04, 49967-500-05, 49967-500-06, 49967-500-07, 49967-500-08
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 HealingPetrolatum OINTMENT
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-500
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM(UNII: 4T6H12BN9U)
(PETROLATUM - UNII:4T6H12BN9U) 		PETROLATUM46.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL(UNII: T5L8T28FGP)
PARAFFIN(UNII: I9O0E3H2ZE)
CERESIN(UNII: Q1LS2UJO3A)
DIMETHICONE(UNII: 92RU3N3Y1O)
CERAMIDE 1(UNII: 5THT33P7X7)
CERAMIDE 3(UNII: 4370DF050B)
CERAMIDE 6 II(UNII: F1X8L2B00J)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE(UNII: 0A5MM307FC)
WATER(UNII: 059QF0KO0R)
SODIUM LAUROYL LACTYLATE(UNII: 7243K85WFO)
LAUROYL PROLINE(UNII: HDI505B669)
CHOLESTEROL(UNII: 97C5T2UQ7J)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
TOCOPHEROL(UNII: R0ZB2556P8)
HYALURONIC ACID(UNII: S270N0TRQY)
PANTHENOL(UNII: WV9CM0O67Z)
PANTOLACTONE(UNII: J288D7O0JS)
PHYTOSPHINGOSINE(UNII: GIN46U9Q2Q)
XANTHAN GUM(UNII: TTV12P4NEE)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49967-500-01340 g in 1 JAR Type 0: Not a Combination Product20/09/2017
2NDC:49967-500-0285 g in 1 TUBE Type 0: Not a Combination Product20/09/2017
3NDC:49967-500-03144 g in 1 TUBE Type 0: Not a Combination Product20/09/2017
4NDC:49967-500-0415 in 1 TRAY 20/09/2017
42.5 g in 1 JAR Type 0: Not a Combination Product20/09/2017
5NDC:49967-500-0510 g in 1 TUBE Type 0: Not a Combination Product20/09/2017
6NDC:49967-500-062 in 1 CARTON 20/09/2017
610 g in 1 TUBE Type 0: Not a Combination Product20/09/2017
7NDC:49967-500-0753.6 g in 1 TUBE Type 0: Not a Combination Product20/09/2017
8NDC:49967-500-081 in 1 BLISTER PACK 20/09/2017
85 g in 1 JAR Type 0: Not a Combination Product20/09/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M016 09/20/2017

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

Establishment
Name Address ID/FEI Business Operations
Accupac, Inc. 071609663 MANUFACTURE(49967-500)

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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