Label: DR WALTONS 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 June 9, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient                     Purpose


    White Petrolatum USP (100%) skin protectantFRONT LABELBACK LABEL

  • DIRECTIONS

    APPLY PRODUCT LIBERALLY, AS OFTEN AS NECESSARY

  • DO NOT USE

    Do not use on deep or puncture wounds, infections or lacerations. Consult your doctor.

  • WARNINGS

    Warning: For external use only.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of Reach of Children. If swallowed get medical help or contact a poison control center right away.

  • PURPOSE

    Uses: A soothing dressing for chapped lips, minor cuts and burns, skin irritations, sunburn, and chafing. Moisturizes hands, feet, elbows, the whole body. Helps remove eye makeup.

  • USES

    A SOOTHING DRESSING FOR CHAPPED LIPS, MINOR CUTS AND BURNS, SKIN IRRITATIONS, SUNBURN, AND CHAFING.

  • INACTIVE INGREDIENT

    WHITE PETROLATUM

  • PRINCIPAL DISPLAY PANEL

    FRONT LABELE

    BACK LABELnter section text here

  • INGREDIENTS AND APPEARANCE
    DR WALTONS PETROLEUM  
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76271-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 226 g  in 226 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76271-002-08226 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/09/2011
    Labeler - Dr. Waltons, Incorporated (041377104)
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