WHITE PETROLATUM OINTMENT [GERITREX LLC]

WHITE PETROLATUM OINTMENT [GERITREX LLC]
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NDC 54162-597-05, 54162-597-28
Set ID 9d2dbef6-f7cf-46ed-b991-d66f6412e2e7
Category HUMAN OTC DRUG LABEL
Packager GERITREX LLC
Generic Name
Product Class
Product Number
Application Number PART347
  • 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)