A AND D (DIMETHICONE AND ZINC OXIDE) CREAM [BAYER HEALTHCARE LLC.]

A AND D (DIMETHICONE AND ZINC OXIDE) CREAM [BAYER HEALTHCARE LLC.]
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NDC 11523-1314-1, 11523-1314-2, 11523-1314-3
Set ID 297e62e4-5282-4733-b3f7-f63a16e8ddee
Category HUMAN OTC DRUG LABEL
Packager Bayer HealthCare LLC.
Generic Name
Product Class
Product Number
Application Number PART347
  • Drug Facts
  • ACTIVE INGREDIENT

    Dimethicone, Zinc Oxide

    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 - 113g Carton

    PEDIATRICIAN RECOMMENDED

    A+D®

    Treat

    Diaper Rash Cream

    WITH DIMETHICONE AND ZINC OXIDE

    • Helps treat & calm diaper rash
    • Allows skin to heal naturally

    NET WT 4 OZ (113g)

    moisturizing

    with ALOE

    4 oz carton

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  • INGREDIENTS AND APPEARANCE
    A AND D 
    dimethicone and zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-1314
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 11.09 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 110.09 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color white (White cream) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11523-1314-2 1 in 1 CARTON 12/25/2009
    1 113 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:11523-1314-3 1 in 1 CARTON 12/25/2009
    2 85 g in 1 TUBE; Type 0: Not a Combination Product
    3 NDC:11523-1314-1 1 in 1 CARTON 12/25/2009
    3 42.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 12/25/2009
    Labeler - Bayer HealthCare LLC. (112117283)
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