CERAVE DEVELOPED WITH DERMATOLOGISTS HEALING- petrolatum ointment

CeraVe Developed with Dermatologists Healing by

Drug Labeling and Warnings

CeraVe Developed with Dermatologists Healing by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc., Product Quest Mfg, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Petrolatum 46.5%

Purpose

Skin protectant (ointment)

Uses

• temporarily protects and helps relieve chafed, chapped or cracked skin
• temporarily protects minor: cuts, scrapes, burns
• helps protect from the drying effects of wind and cold weather

Warnings

For external use only

When using this product

• do not get into eyes

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• apply as needed

Inactive ingredients

mineral oil, paraffin, ozokerite, dimethicone, hyaluronic acid, sodium hydroxide, ceramide 1, ceramide 3,

ceramide 6-II, tocopheryl acetate, phytosphingosine, cholesterol, sodium lauroyl lactylate, carbomer, panthenol, water, L-proline, xanthan gum

Questions?

Toll-Free Number 1-888-768-2915

www.cerave.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAVE DEVELOPED WITH DERMATOLOGISTS HEALING 
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	46.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
CERESIN (UNII: Q1LS2UJO3A)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYALURONIC ACID (UNII: S270N0TRQY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
PANTHENOL (UNII: WV9CM0O67Z)
WATER (UNII: 059QF0KO0R)
LAUROYL PROLINE (UNII: HDI505B669)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-500-01	340 g in 1 JAR; Type 0: Not a Combination Product	09/20/2017
2	NDC: 49967-500-02	85 g in 1 TUBE; Type 0: Not a Combination Product	09/20/2017
3	NDC: 49967-500-03	144 g in 1 TUBE; Type 0: Not a Combination Product	09/20/2017
4	NDC: 49967-500-04	15 in 1 TRAY	09/20/2017
4		2.5 g in 1 JAR; Type 0: Not a Combination Product
5	NDC: 49967-500-05	10 g in 1 TUBE; Type 0: Not a Combination Product	09/20/2017
6	NDC: 49967-500-06	2 in 1 CARTON	09/20/2017
6		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/20/2017

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

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