Label: PETROLEUM- 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 11, 2023

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  • Active ingredient

    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 longer than 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 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

    fragrance

  • Adverse  reactions 

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

    PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO.

    5000 KANSAS AVE

    KANSAS CITY, KS 66106

    Best Choice 100% Guaranteed

    www.bestchoicebrand.com

  • Principal Panel Display

    Best Choice

    COMPARE TO VASELINE BABY PETROLEUM JELLY

    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:63941-340
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM100 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-340-27368 g in 1 JAR; Type 0: Not a Combination Product08/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/21/2020
    Labeler - Valu Merchandisers (868703513)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(63941-340)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(63941-340)
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