Label: VASELINE PURE- 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 April 25, 2012

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  • ACTIVE INGREDIENT

    Active ingredient
    WHITE PETROLATUM, USP (100%)
  • PURPOSE

    Purpose
    Skin Protectant
  • INDICATIONS & USAGE

    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

    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.
  • DOSAGE & ADMINISTRATION

    Directions
    ■ apply as needed
  • QUESTIONS

    Questions?  Contact the Consumer Information Center 1-800-457-7084
  • PRINCIPAL DISPLAY PANEL

    VPJ 13 oz. PDP
    Vaseline Petroleum Jelly 13 oz PDP
  • INGREDIENTS AND APPEARANCE
    VASELINE  PURE
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-0034
    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:64942-0034-149 g in 1 JAR
    2NDC:64942-0034-271 g in 1 TUBE
    3NDC:64942-0034-3106 g in 1 JAR
    4NDC:64942-0034-4212 g in 1 JAR
    5NDC:64942-0034-5368 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/18/2010
    Labeler - Conopco Inc. d/b/a Unilever (001375088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Conopco Inc. d/b/a Unilever198786444manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Alberto-Culver USA Inc.021679448manufacture
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