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CeraVe Therapeutic Hand

Medically reviewed on February 20, 2018

Dosage form: cream
Ingredients: DIMETHICONE 10mg in 1g
Labeler: Valeant Pharmaceuticals North America LLC
NDC Code: 0187-2489

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.

Drug Facts

Active ingredient

Dimethicone 1% w/w

Purpose

Protectant

Uses

Helps prevent and temporarily protect chafed, chapped, cracked, dry skin.

Warnings

For external use only.

When using this product avoid contact with eyes.

Rinse with water to remove.

Stop use and ask a doctor

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 right away.

Not to be applied over deep or puncture wounds, infections or lacerations.

Directions

Apply liberally as often as necessary.

Inactive Ingredients

Purified Water, Cyclomethicone and Aluminum/Magnesium Hydroxide Stearate, Polyglyceryl-4 Isostearate and Cetyl PEG/PPG-10/1 Dimethicone and Hexyl Laurate, Sodium Chloride, Niacinamide, Phenoxyethanol, Propylparaben, Ceramide 3, Ceramide 6-II, Ceramide 1, Phytosphingosine, Hyaluronic Acid, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum.

Other Information
Protect this product from excessive heat and direct sun

Questions?

Toll-free number 800-321-4576

www.cerave.com

201248925CA Rev. 06/13

Distributed by:
Valeant Consumer Products,

A division of Valeant Pharmaceuticals

North America LLC

Bridgewater, NJ 08807 USA

VALEANT™

Consumer Products

Package/Label Principal Display Panel

CeraVe®

DEVELOPED WITH DERMATOLOGISTS

Therapeutic

Hand Cream

FOR NORMAL TO DRY SKIN

Helps repair, restore, and

protect skin from harmful

irritants

Non-irritating, water resistant

and fragrance free

Skin protectant

With ceramides, niacinamide,

and hyaluronic acid

Net WT. 3 OZ (85 g)

CERAVE  THERAPEUTIC HAND
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-2489
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
STEARIC ACID 
ALUMINUM HYDROXIDE 
MAGNESIUM HYDROXIDE 
POLYGLYCERYL-4 ISOSTEARATE 
HEXYL LAURATE 
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) 
SODIUM CHLORIDE 
NIACINAMIDE 
PHENOXYETHANOL 
PROPYLPARABEN 
CERAMIDE 3 
CERAMIDE 6 II 
CERAMIDE 1 
PHYTOSPHINGOSINE 
HYALURONIC ACID 
CHOLESTEROL 
SODIUM LAUROYL LACTYLATE 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:0187-2489-251 BOTTLE in 1 CARTON
185 g in 1 BOTTLE
2NDC:0187-2489-315 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/2012
Labeler - Valeant Pharmaceuticals North America LLC (042230623)
Establishment
NameAddressID/FEIOperations
Accupac, Inc071609663MANUFACTURE(0187-2489)

 
Valeant Pharmaceuticals North America LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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