CERAVE BABY DIAPER RASH CREAM- dimethicone and zinc oxide cream 
Valeant Pharmaceuticals North America 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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CeraVe Baby Diaper Rash Cream

Drug Facts

Active ingredientsPurpose

Dimethicone 1%

Skin Protectant

Zinc Oxide 1%

Skin Protectant

Uses

Helps treat and prevent diaper rash
Protects chafed skin due to diaper rash and helps seal out wetness

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Change wet and soiled diapers promptly
Cleanse the diaper area and allow to dry
Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged

Other information

Store between 20 to 25 degrees C (68 to 77 degrees F)

Inactive Ingredients

Water, Cyclopentasiloxane, Cyclohexasiloxane, Aluminum/Magnesium Stearate, Sodium Chloride, Niacinamide, Cetyl PEG/PPG-10/1 Dimethicone, Polyglyceryl-4 Isostearate, Hexyl Laurate, Mineral Oil, Ceramide 3, Ceramide 6-II, Ceramide 1, Tocopheryl Acetate, Sodium hyaluronate, Cholesterol, Allantoin, Phenoxyethanol, Ethylhexylglycerin, Sodium Lauroyl Lactylate, C12-15 Alkyl Benzoate, Phytosphingosine, Isostearic Acid, Xanthan Gum, Carbomer, Polyhydroxystearic Acid

Questions

Toll-free number 800-321-4576

www.cerave.com

Principal Display Panel

NEW

CeraVe®

DEVELOPED WITH DERMATOLOGISTS

baby

Diaper Rash

Cream

InVisibleZinc™ [logo]

Helps treat and prevent

diaper rash. Helps repair

and restore baby’s delicate

skin barrier

Lasts between diaper changes

With essential ceramides

Paraben & sulfate free

Net WT. 3 OZ (85g)

CeraVe Baby Diaper Rash Cream Carton.jpg

Package/Label Principal Display Panel

NEW

CeraVe®

DEVELOPED WITH DERMATOLOGISTS

baby

Diaper Rash

Cream

InVisibleZinc™

Helps treat and prevent diaper

rash. Helps repair and restore

baby’s delicate skin barrier

Lasts between diaper changes

With essential ceramides

Paraben & sulfate free

Net Wt. 5 g (.17 OZ)

DiaperRash Cream Packer container
CERAVE BABY DIAPER RASH CREAM 
dimethicone and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-2221
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
NIACINAMIDE (UNII: 25X51I8RD4)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
ETHYLHEXYL LAURATE (UNII: 8J6M396U72)  
MINERAL OIL (UNII: T5L8T28FGP)  
CERAMIDE NP (UNII: 4370DF050B)  
CERAMIDE AP (UNII: F1X8L2B00J)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
ALLANTOIN (UNII: 344S277G0Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-2221-011 in 1 CARTON12/03/201310/31/2017
185 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0187-2221-021 in 1 CARTON12/03/201310/31/2017
25 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/03/201310/31/2017
Labeler - Valeant Pharmaceuticals North America LLC (042230623)
Establishment
NameAddressID/FEIBusiness Operations
Accupac, Inc.071609663MANUFACTURE(0187-2221)

Revised: 2/2017
 
Valeant Pharmaceuticals North America LLC