Label: 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 May 2, 2023

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  • Active Ingredient

    White Petrolatum USP (100%)

  • Purpose

    Skin protectant

  • Uses

    temporarily protects minor:

    • cuts
    • scrapes
    • burns
    • temporarily protects and helps relieve chapped or cracked skin and lips.
    • helps protect from the drying effects of wind and cold weather.
  • Warnings

    For External use only

    When using this product

    When using this product:

    • do not get into eyes

    See a doctor

    See a doctor if conditions worsen or lasts for more than 7 days

    Do not use

    Do not use on

    • Deep puncture wounds
    • animal bites
    • serious burns

    Keep out of Reach of Children

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

  • Directions

    Directions- Apply as needed

  • Inactive Ingredients

    No Inactive Ingredients

  • Questions or comments?

    1-888-287-1915

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    PETROLEUM JELLY 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-183
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4) WHITE PETROLATUM100 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79903-183-20566 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01605/01/2023
    Labeler - Walmart INC (051957769)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care201901209manufacture(79903-183)
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