CERAVE BABY HEALING- petrolatum ointment 
Bausch Health US LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

CeraVe Baby Healing Ointment 3 oz Tube
CERAVE  BABY HEALING
petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-2487
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM46.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-2487-0385 g in 1 TUBE; Type 0: Not a Combination Product11/07/201608/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/07/201608/01/2017
Labeler - Bausch Health US LLC (831922468)
Establishment
NameAddressID/FEIBusiness Operations
Accupac, Inc.071609663MANUFACTURE(0187-2487)

Revised: 1/2017
 
Bausch Health US LLC