Label: MY FAIR BABY DIAPER RASH- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated December 20, 2020

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  • Active Ingredient

    Zinc Oxide 13%

  • Purpose

    Skin Protection

  • Use

    • Helps treat and prevent diaper rash
    • Soothes and relieves irritated skin
    • Protects your baby's skin from wetness

  • 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

    • Change wet and soiled diapers promptly
    • Cleanse the diaper area
    • Allow to dry
    • Ointment should be applied at every diaper change, specially at bedtime or anytime when exposure to wet diapers may be prolonged

  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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