Label: PAINZAWAY BALM- camphor ointment

  • Category: HUMAN OTC DRUG LABEL

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Updated October 28, 2015

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  • Active Ingredient

    Camphor 4.0%

  • Purpose

    external analgesic ointment

  • Uses:

    Temporary relief of minor aches and pains of muscles and joints associated with arthritis, strains, bruises or simple backache.

  • Warnings

    For external use only.

    Avoid contact with the eyes.

    When using this product, do not:

    heat

    microwave

    use near open flames

    add to hot water or any container where heating water.

    May cause splattering and result in burns.

  • Do Not

    use on wounds or damaged skin

    bandage tightly

  • Stop using and ask a doctor if

    condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • 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.

  • Directions

    Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

    Children under 2 years of age: consult physician.

  • Other information

    Any Questions? 1-800-644-8327

    website: www.botanicchoice.com

    Use only if seal is unbroken.

  • Inactive ingredients

    White petrolatum, cassia oil, clove oil, siberian fir needle oil, cajeput oil, peppermint oil, natural beeswax.

  • SPL UNCLASSIFIED SECTION

    Manufactured by: Indiana Botanic Gardens, Inc.

    3401 W. 37th Avenue Hobart, IN 46342

  • PRINCIPAL DISPLAY PANEL

    Painzaway Balm


    Topical Analgesic


    Net Wt. 2oz.

    image of label
  • INGREDIENTS AND APPEARANCE
    PAINZAWAY BALM 
    camphor ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10578-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    ABIES SIBIRICA LEAF OIL (UNII: XRY0V4VZKZ)  
    CAJUPUT OIL (UNII: J3TO6BUQ37)  
    CHINESE CINNAMON OIL (UNII: A4WO0626T5)  
    CLOVE LEAF OIL (UNII: VCA5491KVF)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10578-040-0129 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:10578-040-0257 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/01/2001
    Labeler - Indiana Botanic Gardens (005421771)
    Establishment
    NameAddressID/FEIBusiness Operations
    Indiana Botanic Gardens005421771manufacture(10578-040)
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