Label: VITAMIN A AND VITAMIN D- petrolatum 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 September 4, 2012

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  • Active Ingredient:

    White Petrolatum (929.3 mg)

  • Purpose:

    Emollient

  • INDICATIONS & USAGE

    Uses:

    • first aid in
    • minor burns
    • scalds
    • sunburn
    • windburn
    • diaper rash
    • chafing
    • chapped skin
    • nipple care
    • abrasions
    • cuts
    • ulcers
  • WARNINGS

    Warnings:

    For external use only.

    Ask doctor before use if you have severe or extensive burns.

    When using this product the treatment of ulcers, severe cuts or wounds should be under the direction of a doctor.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    • cleanse affected area with mild soap and warm water
    • dry thoroughly
    • apply Vitamin A & Vitamin D ointment in a thin layer to the affected area directly to the skin or by spreading on sterile gauze or clean cloth
    • bandage loosely
  • SPL UNCLASSIFIED SECTION

    Other information:

    • do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal
    • store at room temperature
    • see crimp of tube for Lot Number and Exp. Date
  • Inactive Ingredients

    fragrance, lanolin, paraffin, vitamin A (as palmitate), vitamin D

  • SPL UNCLASSIFIED SECTION

    Questions or comments? call toll free 1-800-645-9833

    E. FOUGERA & CO.

    A division of Fougera Pharmaceuticals Inc.

    Melville, NY 11747

    X5110C

    R02/12

    Distributed and "Additional barcode label" applied by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma       74146

  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

    NDC 54868-2877-1

    Vitamin A & Vitamin D Ointment (Emollient)

    To promote healing of minor skin irritaions

    NET WT 4 Oz

    4 oz package label
  • INGREDIENTS AND APPEARANCE
    VITAMIN A AND VITAMIN D 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2877(NDC:0168-0035)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM929.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-2877-11 in 1 CARTON
    1120 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/19/2006
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel(54868-2877)
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