Label: VITAMIN A AND D ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 12, 2018

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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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