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
  • 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 January 30, 2020

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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 finalpart34701/01/2020
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Private Limited726025211manufacture(63868-601)
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