CERAVE BABY MOISTURIZING- dimethicone cream

CeraVe by

Drug Labeling and Warnings

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

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

CERAVE  BABY MOISTURIZING
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-2218
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	12 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 3 (UNII: 4370DF050B)
CERAMIDE 6 II (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)
POTASSIUM PHOSPHATE, DIBASIC (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-2218-05	142 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	12/01/2014

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg, LLC		927768135	MANUFACTURE(0187-2218)