Label: PETROLATUM JELLY WITH COCOA BUTTER- petrolatum jelly

  • Category: HUMAN OTC DRUG LABEL

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 February 24, 2021

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  • DRUG FACTS

    White Petrolatum USP 99.9%

  • PURPOSE

    Skin Protectant

  • Uses

    • provides relief to dry skin and lips
    • offers soothing protection for minor burns
    • provides protection for skin from wind burn and chapping
  • Warnings

    FOR EXTERNAL USE ONLY

    Do not use on

    • deep or puncture wounds
    • infections
    • lacerations
  • Stop Use and ask a doctor if

    • redness or swelling develops
  • Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • apply as needed
  • Inactive Ingredients

    Fragrance

  • PRINCIPAL DISPLAY PANEL

    Principal display

  • INGREDIENTS AND APPEARANCE
    PETROLATUM JELLY WITH COCOA BUTTER 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-0203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52410-0203-2226 g in 1 JAR; Type 0: Not a Combination Product06/24/2016
    2NDC:52410-0203-4368 g in 1 JAR; Type 0: Not a Combination Product06/24/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/24/2016
    Labeler - Shield Line LLC (078518916)
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