CERAVE THERAPEUTIC HAND- 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 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)

CeraVeTherapeuticHandCream
CERAVE  THERAPEUTIC HAND
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-2489
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CERAMIDE NP (UNII: 4370DF050B)  
CERAMIDE AP (UNII: F1X8L2B00J)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
HYALURONIC ACID (UNII: S270N0TRQY)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-2489-251 in 1 CARTON01/01/201208/01/2017
185 g in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0187-2489-315 g in 1 TUBE; Type 0: Not a Combination Product01/01/201208/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/201208/01/2017
Labeler - Bausch Health US, LLC (831922468)
Establishment
NameAddressID/FEIBusiness Operations
Accupac, LLC071609663MANUFACTURE(0187-2489)

Revised: 5/2021
 
Bausch Health US, LLC