A AND D ORIGINAL (LANOLIN AND PETROLATUM) OINTMENT [BAYER HEALTHCARE LLC.]

A AND D ORIGINAL (LANOLIN AND PETROLATUM) OINTMENT [BAYER HEALTHCARE LLC.]
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NDC 11523-0096-1, 11523-0096-2, 11523-0096-4
Set ID aceb23f8-a431-415c-aefd-97047e1aac03
Category HUMAN OTC DRUG LABEL
Packager Bayer HealthCare LLC.
Generic Name
Product Class
Product Number
Application Number PART347
  • SPL UNCLASSIFIED SECTION

    Distributed by Bayer HealthCare LLC, Whippany, NJ, USA, 07981

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Lanolin 15.5% Diaper rash ointment
    Petrolatum 53.4% Skin Protectant
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  • Uses

    • helps treat and prevent diaper rash
    • temporarily protects minor:
      • cuts
      • scrapes
      • burns
    • temporarily protects and helps relieve chapped, chafed or cracked skin and lips
    • protect chafed skin 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

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • for skin protectant use apply as needed
    • for diaper rash use:
      • change wet and soiled diapers promptly
      • cleanse the diaper area, and allow to dry
      • apply ointment 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

    cod liver oil ( contains vitamin A & vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin

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  • PRINCIPAL DISPLAY PANEL - 85 g Carton

    PEDIATRICIAN

    RECOMMENDED

    A+D®

    Prevent

    Original

    Ointment

    DIAPER RASH OINTMENT

    & SKIN PROTECTANT

    • Helps prevent &

      treat diaper rash
    • Forms a protective

      barrier to help

      seal out wetness

    NET WT 3 OZ (85g)

    AandD

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  • INGREDIENTS AND APPEARANCE
    A AND D ORIGINAL 
    lanolin and petrolatum ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-0096
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN 136.4 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 469.9 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    COD LIVER OIL (UNII: BBL281NWFG)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Product Characteristics
    Color orange (Unctuous amber mass) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11523-0096-2 1 in 1 CARTON 06/04/2004
    1 113 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:11523-0096-4 1 in 1 CARTON 06/04/2003
    2 85 g in 1 TUBE; Type 0: Not a Combination Product
    3 NDC:11523-0096-1 1 in 1 CARTON 06/04/2003
    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 06/04/2003
    Labeler - Bayer HealthCare LLC. (112117283)
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