A AND D (PETROLATUM) OINTMENT [HENRY SCHEIN, INC.]

A AND D (PETROLATUM) OINTMENT [HENRY SCHEIN, INC.]
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NDC 0404-0375-05, 0404-0375-47
Set ID 8a420c81-6793-42d8-91a3-0b5f3a28b6bf
Category HUMAN OTC DRUG LABEL
Packager Henry Schein, Inc.
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    White petrolatum 93.5%

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  • PURPOSE

    Purpose: Skin protectant

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  • INDICATIONS & USAGE

    Uses: Temporarily protects minor: cuts, scrapes, burns. Temporarily protects and helps chapped or cracked skin and lips. Helps protect lips from drying effects of wind and cold weather.

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  • WARNINGS

    Warnings: For external use only. Stop use and ask a doctor if: condition worsens, symptoms last for 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

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • DOSAGE & ADMINISTRATION

    Apply as needed.

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  • INACTIVE INGREDIENT

    Inactive ingredients: Corn oil, light mineral oil, vitamin A palmitate, vitamin D.

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  • INGREDIENTS AND APPEARANCE
    A AND D 
    petrolatum ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0404-0375
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 937.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ERGOCALCIFEROL (UNII: VS041H42XC)  
    CORN OIL (UNII: 8470G57WFM)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0404-0375-47 144 in 1 CARTON
    1 NDC:0404-0375-05 5 g in 1 PACKET; 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 12/04/2011
    Labeler - Henry Schein, Inc. (012430880)
    Registrant - ULTRAtab Laboratories, Inc. (151051757)
    Establishment
    Name Address ID/FEI Business Operations
    ULTRAtab Laboratories, Inc. 151051757 manufacture(0404-0375)
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