Label: PRINCESS PETROLEUM- white petrolatum jelly

  • NDC Code(s): 78495-004-01, 78495-004-02, 78495-004-03, 78495-004-04
  • Packager: Ultra Distributors Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 18, 2024

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  • ACTIVE INGREDIENT

    Active Ingredient

    White petrolatum USP (100%)

  • PURPOSE

    Purpose

    Skin protectant

  • INDICATIONS & USAGE

    Uses

    helps protect chapped skin

  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product

    • do not get into eyes
  • ASK DOCTOR

    See a doctor ifcondition lasts more than 7 days.

  • DO NOT USE

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    • If swallowed get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions

    apply as needed

  • Inactive ingredients

    None

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    PRINCESS PETROLEUM JELLY

    NET WT 6 OZ (170 gm)

    label

  • INGREDIENTS AND APPEARANCE
    PRINCESS PETROLEUM 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78495-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM100 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78495-004-01113 g in 1 JAR; Type 0: Not a Combination Product12/01/2020
    2NDC:78495-004-02170 g in 1 JAR; Type 0: Not a Combination Product12/01/2020
    3NDC:78495-004-03226 g in 1 JAR; Type 0: Not a Combination Product12/01/2020
    4NDC:78495-004-04368 g in 1 JAR; Type 0: Not a Combination Product12/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01612/01/2020
    Labeler - Ultra Distributors Inc. (007160073)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(78495-004)
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