Label: PETROLATUM- 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 September 27, 2023

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  • Active ingredients

    White petrolatum USP (100%)

  • purpose

    Skin Protectant

  • Use

    • helps treat and prevent diaper rash
    • protects chafed skin die 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 than 7 days or clear up and occur again withing 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 soiled 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

  • Adverse Reactions

    DISTRIBUTED BY FOODHOLD U.S.A, LLC

    LANDOVER, MD 20785  1-877-846-9949

    Quality guaranteed or your money back.

  • disclaimer

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

  • principal display panel

    Quality with a caring touch

    Cottontails

    baby care

    skin protectant

    fresh scent

    petroleum jelly

    NET WT 13 oz (368 g)

    image description

  • INGREDIENTS AND APPEARANCE
    PETROLATUM 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-519
    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:41520-519-27368 g in 1 JAR; Type 0: Not a Combination Product07/15/1992
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/15/1992
    Labeler - Amerian Sales (809183973)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(41520-519)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(41520-519)
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