Label: COCOA BUTTER PETROLEUM JELLY- white petrolatum jelly

  • 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 December 23, 2020

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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 use on deep puncture wounds, animal bites, or serious burns. Ask a doctor.

  • WHEN USING

    When using this product avoid contact with eyes.

  • STOP USE

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

  • 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.

  • Directions

    apply product liberally, as often as necessary.

  • Inactive ingredients

    Theobroma Cacao (Cocoa) Seed Butter, fragrance

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    COCOA BUTTER PETROLEUM JELLY

    NET WT 7.5 OZ (213 g)

    Principal Display & Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    COCOA BUTTER PETROLEUM JELLY 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0712
    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:0363-0712-01213 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 finalpart34712/24/2020
    Labeler - Walgreens (008965063)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(0363-0712)