CERAVE 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

•
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)

CeraVe Healing Ointment 12 OZ Jar Front and Back Label
CERAVE  HEALING
petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-1950
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)  
.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:0187-1950-12340 g in 1 JAR; Type 0: Not a Combination Product11/02/201508/01/2017
2NDC:0187-1950-0385 g in 1 TUBE; Type 0: Not a Combination Product11/02/201508/01/2017
3NDC:0187-1950-05144 g in 1 TUBE; Type 0: Not a Combination Product11/02/201508/01/2017
4NDC:0187-1950-9915 in 1 TRAY11/02/201508/01/2017
42.5 g in 1 JAR; Type 0: Not a Combination Product
5NDC:0187-1950-3510 g in 1 TUBE; Type 0: Not a Combination Product11/03/201508/01/2017
6NDC:0187-1950-402 in 1 CARTON11/02/201508/01/2017
610 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/02/201508/01/2017
Labeler - Bausch Health US LLC (831922468)

Revised: 1/2016
Document Id: 3f25fcb9-fc04-4d2e-84dc-2a9303e72483
Set id: 323c4a33-a824-4297-b4df-b6ab33e24eb0
Version: 3
Effective Time: 20160107
 
Bausch Health US LLC