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CeraVe Baby Moisturizing by Valeant Pharmaceuticals North America LLC

Dosage form: lotion
Ingredients: DIMETHICONE 10mg in 1mL
Labeler: Valeant Pharmaceuticals North America LLC
NDC Code: 0187-2219

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.

CeraVe Baby Moisturizing Lotion

Drug Facts

Active ingredient

Dimethicone 1%

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

Do not use on

deep or puncture wounds
animal bites
serious burns

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
apply as needed

Other information

do not freeze

Inactive ingredients

purified water, caprylic/capric triglyceride, cetostearyl alcohol, cetyl alcohol, emulsifying wax, phenoxyethanol,niacinamide, ceramide 3, ceramide 6-II, ceramide 1, hyaluronic acid, allantoin, tocopheryl acetate, lauric acid, zinc citrate, polyglyceryl-3 diisostearate, bBehentrimonium methosulfate, sodium lauroyl lactylate, arginine PCA, potassium phosphate, dipotassium phosphate, EDTA, sodium PCA, phytosphingosine, cholesterol, xanthan gum, carbomer, ethylhexylglycerin

Package/Label Principal Display Panel

NEW

CeraVe®

DEVELOPED WITH DERMATOLOGISTS

baby

Moisturizing
Lotion

Protects and maintains baby’s

delicate skin barrier

With essential ceramides

& vitamins

Moisturizes 24 hours

Paraben, sulfate & fragrance free

8 FL OZ (237 mL)

VNT-BABY8-30

Package/Label Principal Display Panel

Back panel –

CERAVE  BABY MOISTURIZING
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-2219
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
MEDIUM-CHAIN TRIGLYCERIDES 
CETOSTEARYL ALCOHOL 
CETYL ALCOHOL 
PHENOXYETHANOL 
NIACINAMIDE 
CERAMIDE 3 
CERAMIDE 6 II 
HYALURONIC ACID 
ALLANTOIN 
.ALPHA.-TOCOPHEROL ACETATE 
LAURIC ACID 
ZINC CITRATE 
POLYGLYCERYL-3 DIISOSTEARATE 
BEHENTRIMONIUM METHOSULFATE 
SODIUM LAUROYL LACTYLATE 
POTASSIUM PHOSPHATE, UNSPECIFIED FORM 
POTASSIUM PHOSPHATE, DIBASIC 
EDETIC ACID 
SODIUM PYRROLIDONE CARBOXYLATE 
PHYTOSPHINGOSINE 
CHOLESTEROL 
XANTHAN GUM 
ETHYLHEXYLGLYCERIN 
Packaging
#Item CodePackage Description
1NDC:0187-2219-01237 mL in 1 BOTTLE
2NDC:0187-2219-0229 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/01/2013
Labeler - Valeant Pharmaceuticals North America LLC (042230623)
Establishment
NameAddressID/FEIOperations
Product Quest Mfg, LLC927768135MANUFACTURE(0187-2219)

Revised: 04/2016
 
Valeant Pharmaceuticals North America LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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