CERAVE BABY 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, Accupac, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Petrolatum 46.5%

Purpose

Skin protectant (ointment)

Uses

■ helps treat and prevent diaper rash

■ protects chafed skin due to diaper rash and helps seal out wetness

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

Keep out of reach of children.

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

Directions

•   ■ change wet and soiled diapers promptly

■ cleanse the diaper area and allow to dry

■ apply ointment liberally as often as necessary, with each diaper change,

especially at bedtime or anytime exposure to wet diapers may be prolonged

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

Package/Label Principal Display Panel

NEW

CeraVe®

DEVELOPED WITH DERMATOLOGISTS

baby

Healing

Ointment

Helps treat and prevent

diaper rash

Skin Protectant

With ceramides

Lanolin Free

Net Wt. 3 OZ (85 g)

[icon/seal] National Eczema Association

INGREDIENTS AND APPEARANCE

CERAVE  BABY HEALING
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-2487
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 NP (UNII: 4370DF050B)
CERAMIDE AP (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: 0187-2487-03	85 g in 1 TUBE; Type 0: Not a Combination Product	11/07/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/07/2016

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc.		071609663	MANUFACTURE(0187-2487)