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 October 12, 2018

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  • Drug Facts

  • Active Ingredients

    White Petrolatum USP 100%

  • Purpose

    Skin Protectant

  • Uses

    • Temporarily protects minor:
    • cuts
    • scrapes
    • burns
    • Temporarily protects and helps chapped lips and cracked skin
  • Warnings

    FOR EXTERNAL USE ONLY

    Stop use and ask a doctor if:

    • condition worsens
    • symptoms last for more than 7 days or clear up and occur again within a few days

    When using this product: avoid contact with eyes

    Don't not use on:

    • deep or puncture wounds
    • animal bites
    • serious burns

    In case of deep puncture wounds or severe burns, consult a physician. If irritation, swelling or pain persists, or infection occurs, discontinue use and consult a physician.

    Keep out of reach of children.

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

  • Directions

    Cleanse area with mild soap and water. Apply White Petrolatum liberally.

  • Other information

    • Avoid excessive heat and humidity
    • Store at 15-30°C (59-86°F)
  • PRINCIPAL DISPLAY PANEL

    28g label

  • INGREDIENTS AND APPEARANCE
    WHITE PETROLATUM 
    white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-597
    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
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) 0.001 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-597-2828 g in 1 TUBE; Type 0: Not a Combination Product09/27/2018
    2NDC:54162-597-055 g in 1 POUCH; Type 0: Not a Combination Product07/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/31/2015
    Labeler - GERITREX LLC (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    GERITREX LLC112796248manufacture(54162-597)
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