A AND A DIAPER RASH CREAM (DIMETHICONE AND ZINC OXIDE) CREAM [BIOZONE LABORATORIES, INC.]

A AND A DIAPER RASH CREAM (DIMETHICONE AND ZINC OXIDE) CREAM [BIOZONE LABORATORIES, INC.]
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NDC 55379-407-04
Set ID 45a42b10-e42a-4e98-95b8-777f995c5e09
Category HUMAN OTC DRUG LABEL
Packager BioZone Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART347
  • Drug Facts
  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Dimethicone 1% Diaper rash Cream
    Zinc Oxide 10% Diaper rash Cream
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  • Uses

    • helps treat and prevent diaper rash
    • protects minor skin irritation due to diaper rash and helps seal out wetness
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  • 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 right away.

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  • 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 when exposure to wet diapers may be prolonged
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  • Other information

    store between 20°C to 25 °C ( 68° to 77°F)

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  • Inactive Ingredients

    Aloe barbadensis extract, benzyl alcohol, coconut oil, cod liver oil ( contains vitamin A & Vitamin D), fragrance, glyceryl oleate, light mineral oil, ozokerite, paraffin, propylene glycol, sorbitol, synthetic beeswax, water

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  • Principal Display Panel

    A+A Diaper Rash Cream

    with DIMETHICONE AND ZINC OXIDE

    Helps treat and calm diaper rash

    Allows Skin to heal naturally

    A+A Diaper Rash Cream

    A+A Diaper Rash Cream

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  • INGREDIENTS AND APPEARANCE
    A AND A DIAPER RASH CREAM  
    dimethicone and zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55379-407
    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 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 100 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55379-407-04 113 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part347 06/15/2013
    Labeler - BioZone Laboratories, Inc. (555564293)
    Establishment
    Name Address ID/FEI Business Operations
    BioZone Laboratories, Inc. 555564293 manufacture(55379-407)
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