Label: VASELINE LIP THERAPY ADVANCED FORMULA- petrolatum ointment

  • 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 October 2, 2012

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  • ACTIVE INGREDIENT

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

    Purpose:
    Skin Protectant
  • INDICATIONS & USAGE

    Uses
    ▪      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
  • INACTIVE INGREDIENT

    Inactive Ingredient  Flavor
  • QUESTIONS

    Questions?  Call 1-800-457-7084
  • PRINCIPAL DISPLAY PANEL

    VLT 0.35 oz. PDPVaseline Lip Therapy Advanced 0.35 oz PDP

  • PRINCIPAL DISPLAY PANEL

    VLT blister cardVaseline Lip Therapy Advanced 0.35 oz blister card

  • INGREDIENTS AND APPEARANCE
    VASELINE  LIP THERAPY ADVANCED FORMULA
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-0053
    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:64942-0053-21 in 1 BLISTER PACK
    1NDC:64942-0053-110 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/20/2004
    Labeler - Conopco Inc. d/b/a Unilever (001375088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Conopco Inc. d/b/a Unilever198786444manufacture(64942-0053)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alberto-Culver USA Inc.021679448manufacture(64942-0053)
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