VITAMIN A AND D OINTMENT [GERITREX LLC]

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VITAMIN A AND D OINTMENT [GERITREX LLC]
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NDC 54162-000-02, 54162-000-04, 54162-000-05
Set ID e6f217fc-d753-49f9-a467-b8bc7f7e7885
Category HUMAN OTC DRUG LABEL
Packager GERITREX LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • Drug Facts

  • Active Ingredient

    White Petrolatum 95%

  • Purpose

    A Skin protectant

  • Uses

    For the temporary protection of minor cuts, scrapes, burns. Protects chafed skin

  • Warnings

    FOR EXTERNAL USE ONLY.

    When using this product: Avoid contact with eyes.

    DO NOT apply over deep or punctured wounds, infections or lacerations

    IF CONDITION WORSENS OR DOES NOT
    IMPROVE WITHIN 7 DAYS STOP USE AND
    CONSULT A PHYSICIAN.

    KEEP OUT OF REACH OF CHILDREN.

    In the event of accidental ingestion contact a Poison Control Center right away.

  • Directions

    Cleanse area with mild soap and water. Apply liberally as often as necessary.

  • Storage

    • Store at Controlled Room Temperature 15°-30°C (59°-86°F).
  • Inactive ingredients

    Cod Liver Oil, Lanolin, Mineral Oil, Paraffin Wax, Phenoxyethanol, Vitamin A and Vitamin D

  • Label

    113g Label

    56g Label

    5g Label

  • INGREDIENTS AND APPEARANCE
    VITAMIN A AND D 
    vitamin a and d ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30.8 g  in 56 g
    Inactive Ingredients
    Ingredient NameStrength
    COD LIVER OIL (UNII: BBL281NWFG)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    VITAMIN A (UNII: 81G40H8B0T)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-000-04113 g in 1 TUBE; Type 0: Not a Combination Product01/01/2019
    2NDC:54162-000-0256 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
    3NDC:54162-000-055 g in 1 POUCH; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2018
    Labeler - GERITREX LLC (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    GERITREX LLC112796248manufacture(54162-000)
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