MY FAIR BABY DIAPER RASH (ZINC OXIDE) CREAM [DELTA BRANDS INC]

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MY FAIR BABY DIAPER RASH (ZINC OXIDE) CREAM [DELTA BRANDS INC]
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NDC 20276-321-01, 20276-321-02, 20276-321-03, 20276-321-04, 20276-321-05, 20276-321-06, 20276-321-10, 20276-321-15, 20276-321-20, 20276-321-25, 20276-321-30, 20276-321-45
Set ID 90756439-3ec0-4c89-90a1-28318810c3b7
Category HUMAN OTC DRUG LABEL
Packager Delta Brands Inc
Generic Name
Product Class
Product Number
Application Number PART347
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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:20276-321
    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:20276-321-011 in 1 CARTON08/30/2011
    1NDC:20276-321-1028 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:20276-321-021 in 1 CARTON08/30/2011
    2NDC:20276-321-1543 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:20276-321-031 in 1 CARTON08/30/2011
    3NDC:20276-321-2057 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:20276-321-041 in 1 CARTON08/30/2011
    4NDC:20276-321-2570 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:20276-321-051 in 1 CARTON08/30/2011
    5NDC:20276-321-3084 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:20276-321-061 in 1 CARTON02/01/2019
    6NDC:20276-321-45127 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 - Delta Brands Inc (102672008)
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