CERAVE BABY MOISTURIZING- dimethicone lotion

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]

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 –

INGREDIENTS AND APPEARANCE

CERAVE  BABY MOISTURIZING
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-2219
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 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
NIACINAMIDE (UNII: 25X51I8RD4)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
HYALURONIC ACID (UNII: S270N0TRQY)
ALLANTOIN (UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAURIC ACID (UNII: 1160N9NU9U)
ZINC CITRATE (UNII: K72I3DEX9B)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z)
EDETIC ACID (UNII: 9G34HU7RV0)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-2219-01	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2013
2	NDC: 0187-2219-02	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/01/2013

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg, LLC		927768135	MANUFACTURE(0187-2219)