Label: COCOA BUTTER PETROLEUM JELLY- white petrolatum jelly

  • NDC Code(s): 30400-503-01, 30400-503-02
  • Packager: Jell Pharmaceuticals Pvt. Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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  • Active Ingredient

    White Petrolatum USP (99%)

  • Purpose

    Skin protectant

  • Uses

    • For the temporary protection of minor cuts, scrapes, burns
    • Helps to temporarily protect chafed, chapped, cracked or windburned skin and lips.

  • Warnings

    For External Use Only

  • DO NOT USE

    Do not useon deep puncture wounds, animal bites, or serious burns. Ask a doctor.

  • WHEN USING

    When using this productavoid contact with eyes.

  • STOP USE

    Stop use and ask doctorif condition worsens or does not improve within 7 days.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of childrenif swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    apply product liberally, as often as necessary.

  • Inactive ingredients

    Theobroma Cacao (Cocoa) Seed Butter, fragrance

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    COCOA BUTTER PETROLEUM JELLY 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30400-503
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCOA BUTTER (UNII: 512OYT1CRR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30400-503-0149 g in 1 JAR; Type 0: Not a Combination Product12/24/2020
    2NDC:30400-503-02100 g in 1 JAR; Type 0: Not a Combination Product12/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01612/24/2020
    Labeler - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(30400-503)
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