Label: PETROLEUM SKIN PROTECTANT- 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 January 27, 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 protects from the drying effects of wind and cold weather
  • Warnings

    For external use only

  • When using this product

    • do not get into eyes
  • See a 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

  • Dislcaimer

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

    Questions or Comments?

    1-800-616-2471

  • ADVERSE REACTION

    DISTRIBUTED BY

    MAJOR PHARMACEUTICALS

    17177 N Laurel Park Drive, Suite 233

    31778 ENTERPRISE DRIVE

    LIVONIA, MI 48150

  • principal display panel

    NDC 0904-5731-82

    MAJOR

    100% Pure

    Petroleum Jelly

    White Petrolatum Skin Protectant

    Compare to Vaseline*

    NET WT 13 OZ (368 g)

    image description

  • INGREDIENTS AND APPEARANCE
    PETROLEUM SKIN PROTECTANT 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5731
    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:0904-5731-82368 g in 1 JAR; Type 0: Not a Combination Product07/11/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/11/2007
    Labeler - Major (191427277)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(0904-5731)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(0904-5731)
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