Label: WHITE 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 August 30, 2012

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  • 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
  • INACTIVE INGREDIENT

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0168-0053
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0168-0053-16453.6 g in 1 JAR
    2NDC:0168-0053-211 in 1 CARTON
    228.35 g in 1 TUBE
    3NDC:0168-0053-31144 in 1 CARTON
    328.35 g in 1 TUBE
    4NDC:0168-0053-451 in 1 CARTON
    45 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/1968
    Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)
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