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White Petrolatum (E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.)

Available Formats

Dosage Form Package Information Links
OINTMENT 1 TUBE in 1 CARTON (0168-0053-21) > 28.35 g in 1 TUBE Label Information
OINTMENT 144 TUBE in 1 CARTON (0168-0053-31) > 28.35 g in 1 TUBE Label Information
OINTMENT 1 PACKET in 1 CARTON (0168-0053-45) > 5 g in 1 PACKET Label Information
OINTMENT 453.6 g in 1 JAR (0168-0053-16) Label Information

Complete White Petrolatum Information

  • Active Ingredient:

    White Petrolatum USP 100%


  • Purpose:

    Skin Protectant


  • INDICATIONS & USAGE

    Uses:

    • temporary protection of minor
    • cuts
    • scrapes
    • burns
    • sunburn
    • chafed or chapped skin
    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps protect from wetness

  • WARNINGS

    Warnings:

    For external use only

    When using this product

    • avoid contact with eyes
    • not to be applied over deep or puncture wounds, infections or lacerations

    Stop use and ask a doctor if

    • the condition persists or gets worse
    • if a rash or other allergic reaction develops

  • Keep out of reach of children.

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


  • DOSAGE & ADMINISTRATION

    Directions:

    • change wet and soiled diapers promptly
    • cleanse the diaper area and allow to dry
    • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

  • SPL UNCLASSIFIED SECTION

    Other information:

    • store at room temperature 15°-30°C (59°-86°F)
    • do not sure if seal is broken or missing

  • SPL UNCLASSIFIED SECTION

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


  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

    Fougera®

    NDC 0168-0053-16

    White Petrolatum USP

    Skin Protectant

    NET WT 453.6g (1 lb.)

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

    Fougera®

    NDC 0168-0053-21

    White Petrolatum USP

    Skin Protectant

    NET WT 28.35g (1 Oz)

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

    Fougera®

    NDC 0168-0053-21

    White
    Petrolatum USP

    Skin Protectant

    Soothes minor skin irritations due to:
    minor burns - scrapes - abrasions

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

    Fougera®

    NDC 0168-0053-45

    White Petrolatum USP

    Skin Protectant

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

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

    Fougera®

    NDC 0168-0053-45

    White Petrolatum USP

    Skin Protectant

    This product is available as tubes at pharmacy.

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

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

  • INGREDIENTS AND APPEARANCE
    WHITE PETROLATUM 
    white petrolatum ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0168-0053
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 1 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0168-0053-16 453.6 g in 1 JAR
    2 NDC:0168-0053-21 1 in 1 CARTON
    2 28.35 g in 1 TUBE
    3 NDC:0168-0053-31 144 in 1 CARTON
    3 28.35 g in 1 TUBE
    4 NDC:0168-0053-45 1 in 1 CARTON
    4 5 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 01/01/1968
    Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)