CERAVE BABY MOISTURIZING- dimethicone cream 
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

Dimethicone 1.2%

Purpose

Skin protectant

Uses

temporarily protects and helps relieve chafed, chapped or cracked skin.
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 right away.

Directions

apply as needed

Inactive ingredients

water, glycerin, cetearyl alcohol, caprylic/capric triglycerides, cetyl alcohol, ceteareth-20, petrolatum, ceramide 3, ceramide 6-II, ceramide 1, hyaluronic acid, cholesterol, phenoxyethanol, behentrimonium methosulphate, potassium phosphate, dipotassium phosphate, ethylhexylglycerin, sodium lauroyl lactylate, disodium EDTA, phytosphingosine, carbomer, xanthan gum, sodium hydroxide

Questions?

Toll-free number 800-321-4576

www.cerave.com

VALEANT™

Consumer Products

Distributed by:

Valeant Consumer Products

a division of

Valeant Pharmaceuticals

North America LLC,

Bridgewater, NJ 08807 USA

9399801 REV. 11/14

Package/Label Principal Display Panel

NEW

CeraVe®

DEVELOPED WITH DERMATOLOGISTS

baby

Moisturizing
Cream

Skin protectant

Protects and maintains baby’s

delicate skin barrier

With ceramides 1, 3, and 6-II

Moisturizes & protects 24 hours

Paraben & fragrance free

Net Wt. 5 OZ (142 g)

Cerave Baby Moisturizing Cream Carton
CERAVE  BABY MOISTURIZING
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-2218
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE12 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
PETROLATUM (UNII: 4T6H12BN9U)  
CERAMIDE NP (UNII: 4370DF050B)  
CERAMIDE AP (UNII: F1X8L2B00J)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
HYALURONIC ACID (UNII: S270N0TRQY)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)  
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-2218-05142 g in 1 TUBE; Type 0: Not a Combination Product12/01/201408/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/01/201408/01/2017
Labeler - Bausch Health US LLC (831922468)

Revised: 2/2015
 
Bausch Health US LLC