Label: PAINZAWAY BALM- camphor ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 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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