Label: PETROLEUM- white petrolatum jelly

  • NDC Code(s): 63868-601-04, 63868-601-13
  • Packager: QUALITY CHOICE (Chain Drug Marketing Association)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • Warning

    For External Use Only

  • Active Ingredient

    Name                                                                         Purpose

    White Petrolatum  100% USP ..............................   Skin Protectant

  • Inactive Ingredsient

    Water

  • Purpose

    Skin Protectant

  • Keep out of the reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222)right away

  • Uses

    Temporarily Protects:

    minor cuts, scrapes, burns and helps relieve chapped or cracked skin and lips from the drying effects of wind and cold weather

  • Dosage

    Applied as needed.

  • Label

    NDC:63868-601-13

    Label Image

  • INGREDIENTS AND APPEARANCE
    PETROLEUM 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM100 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-601-13368 g in 1 JAR; Type 0: Not a Combination Product01/01/2020
    2NDC:63868-601-04113 g in 1 JAR; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00301/01/2020
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Private Limited726025211manufacture(63868-601)
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