Label: VITAMIN A AND VITAMIN 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 September 5, 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

  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

    NDC 0168-0035-01

    Fougera®

    Vitamin A & Vitamin D Ointment

    (Emollient)

    NET WT 56.70 g (2 Oz)

    FOR EXTERNAL USE ONLY

    DO NOT USE IN THE EYES

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

    Fougera®

    NDC 0168-0035-01

    Vitamin A & Vitamin D Ointment (Emollient)

    To promote healing of minor skin irritaions

    NET WT 2 Oz (56.70 g)

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON
  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

    Fougera®

    NDC 0168-0035-45

    Vitamin A & Vitamin D Ointment

    (Emollient)

    This product available in tubes at pharmacy

    NET WT 5 g (approx. 5/32 Oz)

    E. FOUGERA & CO.
    A division of Fougera Pharamceuticals Inc., Melville, NY 11747

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

    NDC 0168-0035-45

    Fougera®

    Vitamin A & Vitamin D
    Ointment

    (Emollient)

    This product available in tubes at pharmacy

    1 GROSS
    5 g (approx. 5/32 Oz) FOILPACS®

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON
  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

    Fougera®

    NDC 0168-0035-16

    Vitamin A & Vitamin D
    Ointment (Emollient)

    NET WT 453.6 g (1 lb)

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
  • INGREDIENTS AND APPEARANCE
    VITAMIN A AND VITAMIN D 
    vitamin a and vitamin d ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:0168-0035-011 in 1 CARTON
    156.70 g in 1 TUBE
    2NDC:0168-0035-0272 in 1 CARTON
    256.70 g in 1 TUBE
    3NDC:0168-0035-041 in 1 CARTON
    3113.4 g in 1 TUBE
    4NDC:0168-0035-451 in 1 CARTON
    45 g in 1 PACKET
    5NDC:0168-0035-16453.6 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/1981
    Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)
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