Label: PETROLEUM- white petrolatum jelly

  • NDC Code(s): 50594-069-27, 50594-069-96
  • Packager: Big Lots
  • 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 January 20, 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

    • do not get into eyes
  • See doctor if

    condition lasts more than 7 days

  • Do not use on

    • deep or 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

    apply as needed

  • Inactive ingredients

    None

  • Disclaimer

    *This product is not manufactured or distributed by Unilever, distributor of Vaseline

    **Parabens and Phthalates are not normally in this product.

  • SPL UNCLASSIFIED SECTION

    Manufactured for Big Lots

    By: Vi-Jon, LLC

    8515 Page Avenue

    St. Louis, MO 63114

  • Principal Panel Display

    SOUNDBODY

    Compare to Vaseline*

    Petroleum Jelly

    White Petrolatum

    Skin Protectant

    • 100% Pure
    • Hypoallergenic
    • Phthalate free**
    • Paraben free**

    NET WT 13 oz (368 g)

    image description

  • Principal Panel Display

    B loved

    COMPARE TO VASELINE

    100% PURE PETRLEUM JELLY

    petroleum jelly

    white petrolatum - skin protectant - 100% pure

    NET WT 7.5 OZ (212 g)

    image description

  • INGREDIENTS AND APPEARANCE
    PETROLEUM 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50594-069
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50594-069-27368 g in 1 JAR; Type 0: Not a Combination Product08/16/2018
    2NDC:50594-069-96212 g in 1 JAR; Type 0: Not a Combination Product08/16/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/16/2018
    Labeler - Big Lots (017885351)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(50594-069)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(50594-069)
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