Label: PETROLEUM JELLY- 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 May 3, 2018

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  • Active Ingredient

    White Petrolatum USP (100%)

  • 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.

  • When using this product

    do not get into eyes.

  • See a doctor

    if condition lasts more than 7 days.

  • 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.

  • Directions

    Apply as needed

  • Front Label

    Front LabelFront Label

  • Back Label

    Back LabelBack Label

  • INGREDIENTS AND APPEARANCE
    PETROLEUM JELLY 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43749-720
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM100 g  in 100 g
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43749-720-04113 g in 1 JAR; Type 0: Not a Combination Product12/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/10/2017
    Labeler - Unipack, Inc. (009248480)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack, Inc.009248480manufacture(43749-720)
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Safety

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Related Resources

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