CERAVE HEALING- petrolatum ointment

CeraVe by

Drug Labeling and Warnings

CeraVe by is a Otc medication manufactured, distributed, or labeled by Valeant Pharmaceuticals North America LLC, Product Quest Mfg, LLC, Accupac, Inc.. 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 800-321-4576

www.cerave.com

Principal Display Panel

NEW

CeraVe

DEVELOPED WITH DERMATOLOGISTS

Healing

Ointment

Protects and soothes dry,

cracked & chafed skin

NON - GREASY FEEL

[icon/seal] National Eczema Association

Skin Protectant

With ceramides

Net Wt. 12 OZ (340 g)

INGREDIENTS AND APPEARANCE

CERAVE  HEALING
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-1950
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: 0187-1950-12	340 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 0187-1950-03	85 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 0187-1950-05	144 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 0187-1950-99	15 in 1 TRAY
4		2.5 g in 1 JAR; Type 0: Not a Combination Product
5	NDC: 0187-1950-35	10 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 0187-1950-40	2 in 1 CARTON
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	11/02/2015

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg, LLC		927768135	MANUFACTURE(0187-1950)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc.		071609663	MANUFACTURE(0187-1950)