Label: NATURES PURITY SCENTED- white 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 June 29, 2012

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  • ACTIVE INGREDIENT

    Active IngredientPetrolatum 99.9%

  • PURPOSE

    Purpose
    Skin protectant
  • INDICATIONS & USAGE

    Uses:

    • Temporarily protects minor cuts, scrapes or 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.
  • STOP USE

    Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days

  • DO NOT USE

    Do not use on deep or puncture wounds animal bites serious burns

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions:

    Apply to a clean and dry diaper area as often as necessary

  • INACTIVE INGREDIENT

    Inactive ingredients: Fragrance
  • PRINCIPAL DISPLAY PANEL

    MM1

  • INGREDIENTS AND APPEARANCE
    NATURES PURITY  SCENTED
    white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52039-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.9 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52039-001-06170 g in 1 JAR
    2NDC:52039-001-12340 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/18/2012
    Labeler - AMERICAN EAGLE STAR IMPORTS INC. (826952769)
    Establishment
    NameAddressID/FEIBusiness Operations
    SUPRIMA COSMO-TECH676588215manufacture
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