Label: VASELINE PURE BABY- 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 (99.96%)
  • PURPOSE

    Purpose
    skin protectant
  • INDICATIONS & USAGE

    Uses
    ￭ helps treat and prevent diaper rash
    ￭ protects chafed skin due to diaper rash
    ￭ helps seal out wetness

  • WARNINGS

    Warnings
    For External Use Only

    Do not use over deep or puncture wounds, infections or lacerations.  Ask a doctor.

    When using this product do not get into eyes

    Stop use and ask a doctor if condition worsens or does not improve within 7 days.

    Keep out of reach of children.  If swallowed get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions
    ￭     change wet and soiled diapers promptly
    ￭ cleanse diaper area; allow to dry
    ￭     apply product liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged
  • INACTIVE INGREDIENT

    Inactive ingredient  FRAGRANCE
  • QUESTIONS

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

    VPJ Baby 13 oz PDP
    Vaseline PJ Baby 13 oz PDP
  • INGREDIENTS AND APPEARANCE
    VASELINE  PURE BABY
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-0016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    petrolatum (UNII: 4T6H12BN9U) (petrolatum - UNII:4T6H12BN9U) petrolatum99.96 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-0016-1368 g in 1 JAR
    2NDC:64942-0016-271 g in 1 TUBE
    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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