Label: PETROLEUM- white petrolatum jelly

  • NDC Code(s): 11344-566-18, 11344-566-27, 11344-566-54, 11344-566-96
  • Packager: Vi-Jon, LLC
  • 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 August 30, 2021

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  • Active ingredient

    White petrolatum USP (99.8%)

  • 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

  • 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

    apply as needed

  • Inactive ingredient

    fragrance (lavender, chamomile)

  • SPL UNCLASSIFIED SECTION

    *Typically this product would not include parabens

    Manufactured by: Vi-Jon, Inc., St. Louis, MO 63114

    Questions or Comments? 1-888-593-0593

  • principal display panel

    Mountain falls

    paraben and phthalate free*

    hypoallergenic

    Petroleum Jelly Skin Protectant

    Lavender + Chamomile

    Made in the USA with US and foreign parts

    NET WT 13 oz (368 g)

    image description

  • INGREDIENTS AND APPEARANCE
    PETROLEUM 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-566
    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:11344-566-1870 g in 1 JAR; Type 0: Not a Combination Product07/29/2010
    2NDC:11344-566-54106 g in 1 JAR; Type 0: Not a Combination Product07/29/2010
    3NDC:11344-566-96212 g in 1 JAR; Type 0: Not a Combination Product07/29/2010
    4NDC:11344-566-27368 g in 1 JAR; Type 0: Not a Combination Product07/29/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/29/2010
    Labeler - Vi-Jon, LLC (150931459)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(11344-566)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(11344-566)
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