CERAVE THERAPEUTIC HAND- dimethicone cream

CeraVe by

Drug Labeling and Warnings

CeraVe by is a Otc medication manufactured, distributed, or labeled by Valeant Pharmaceuticals North America LLC, Accupac, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

CERAVE  THERAPEUTIC HAND
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-2489
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 3 (UNII: 4370DF050B)
CERAMIDE 6 II (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-2489-25	1 in 1 CARTON
1		85 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0187-2489-31	5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/01/2012

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc		071609663	MANUFACTURE(0187-2489)