MY FAIR BABY DIAPER RASH- zinc oxide cream 
Anicare Pharmaceuticals Pvt. Ltd.

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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diaper rash cream

Active Ingredient

Zinc Oxide 13%

Purpose

Skin Protection

Use

Warnings

For external use only

When using this product

Avoid contact with the eyes

Stop use and ask a doctor if

Condition worsens or does not improve within 7 days or symptoms 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

Directions

Other Information

Store at 20º to 25°C (68° to 77°F)

Inactive Ingredients

Water, Mineral Oil, Petrolatum, Cetyl Alcohol, Ceteareth-25, Glyceryl Monostearate, Beeswax, Microcrystaline Wax, Fragrance, Dimethicone, Aloe Barbadensis Leaf Extract (Aloe Vera), Tocopheryl Acetate, Methylparaben, Propylparaben, Methylchloroisothiazolinone, Methylisothiazolinone, Carbomer

Carton Label

Package Label

MY FAIR BABY  DIAPER RASH
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47046-179
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETEARETH-25 (UNII: 8FA93U5T67)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
WHITE WAX (UNII: 7G1J5DA97F)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47046-179-021 in 1 CARTON08/30/2011
1NDC:47046-179-0128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/30/2011
Labeler - Anicare Pharmaceuticals Pvt. Ltd. (916837425)

Revised: 12/2020
Document Id: b6e209d2-ad7c-e39e-e053-2a95a90aec68
Set id: b6e209c8-09be-eac2-e053-2a95a90a4751
Version: 1
Effective Time: 20201220
 
Anicare Pharmaceuticals Pvt. Ltd.