Label: ORIGINAL PETROLEUM- 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 December 5, 2022

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  • Active Ingredient

    WHITE PETROLATUM, USP (100%)

  • Purpose

    Skin Protectant

  • Uses

    • Temporarily protects minor, cuts, scrapes, and burns
    • Temporarily protects and helps relieve chapped or cracked skin and lips
    • Helps protect from the drying effects of wind and cold weather
  • Directions:

    Apply as needed

  • Warnings:

    For External Use Only

  • 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.

  • inactive ingredient

  • Package Display

    Original Petroleum Jelly

    Skin Protectant

    Protects:

    • Minor Cuts
    • Burns
    • Scrapes

    13 oz. (369 g)

    front

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  • INGREDIENTS AND APPEARANCE
    ORIGINAL PETROLEUM 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42669-211
    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:42669-211-01106 g in 1 JAR; Type 0: Not a Combination Product12/05/2022
    2NDC:42669-211-02369 g in 1 JAR; Type 0: Not a Combination Product12/05/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/26/2015
    Labeler - Davion, Inc. (174542928)
    Registrant - Davion, Inc. (174542928)