Label: PETROLEUM- white petrolatum jelly

  • NDC Code(s): 53942-519-27
  • Packager: Demoulas Supermarkets, Inc
  • 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 April 5, 2022

If you are a consumer or patient please visit this version.

  • Active ingredients

    White Petrolatum USP (100%)

  • Purpose

    Skin Protectant

  • Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash
    • helps seal out wetness
  • Warnings

    For external use only

  • Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • When using this product

    • do not get into eyes
  • Stop use and ask a doctor

    • if condition worsens 
    • symptoms last longer then 7 days or clear up and occur again within a few days
  • Keep out of reach of children

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

  • Directions

    • change wet and soilded diapers promptly
    • cleanse the diaper area, and allow to dry
    • apply product liberally as often as necessary, with each diaper change, and especially at bedtime or anytime when exposure to wet diapers may be prolonged
  • Inactive ingredient

    None

  • Disclaimer

    This product is not manufactured or distributed by Unilever, distributer of Vaseline Baby

  • Adverse reaction

    Distributed By

    Demoulas Supermarkets, Inc

    875 East Street

    Tweksbury, MA 01876

    Made in the U.S.A. with U.S. and foreign components

  • principal display panel

    MORE FOR YOUR DOLLAR

    Compare to Vaseline Baby

    MARKET BASKET

    BABY

    petroleum

    jelly

    Skin

    Protectant

    NET WT 13 oz (368 g)

    image description

  • INGREDIENTS AND APPEARANCE
    PETROLEUM 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-519
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1000 mg  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53942-519-27368 g in 1 JAR; Type 0: Not a Combination Product09/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/01/2010
    Labeler - Demoulas Supermarkets, Inc (007869647)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(53942-519)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(53942-519)