Label: BIO 2 BRAZILIAN HEAT BRAZILIAN HEAT- menthol liquid

  • 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 March 15, 2012

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  • Active Ingredient

    Active Ingredient
    Menthol 7.0%


  • Purpose

    Purpose
    External analgesi
  • Use

    • For the temporary relief of pain and soreness.
    • May help distract from pain.
    • May provide a cooling sensation.
  • Warnings

    Only for external use.

    Flammable. Keep away from heat
    or flame.

    • Do not apply to irritated skin or if
      excessive irritation develops
    • Avoid getting into the eyes or
      mucos membranes.

  • Stop use and ask a physician if

    Stop use and ask a physician
    symptoms persist.
  • Keep out of reach of children

    If swallowed, seek medical advice
    or contact a Poison Control Center
    immediately.
  • Directions

    Spray a light mist over the affected
    area up to 6 times daily. Allow to
    air dry.


  • INACTIVE INGREDIENT

    Alcohol, Dimethyl Sulfone (MSM),
    Eucalyptus Oil, Gelidiella acerosa,
    Hydrogen Peroxide and Chlorine
    Dioxide, Hypnea musciformis,
    Magnesium, Peppermint Oil,
    Sargassum filipendula,
    Sodium, Sorbitol, Water, Zinc

  • Questions:

    Paso Robles, CA 93446 USA
    805.238.0300
    www.bio2USA.com
    Made in the U.S.A.

  • PRINCIPAL DISPLAY PANEL

    Placeholder Text

    Bio 2 Brazilian Heat

  • INGREDIENTS AND APPEARANCE
    BIO 2 BRAZILIAN HEAT  BRAZILIAN HEAT
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-036
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol4.2 mL  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GELIDIELLA ACEROSA (UNII: T91K54D6M1)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    CHLORINE DIOXIDE (UNII: 8061YMS4RM)  
    HYPNEA MUSCIFORMIS (UNII: W6FF9R1FJV)  
    MAGNESIUM (UNII: I38ZP9992A)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SARGASSUM FILIPENDULA (UNII: 55P66J5H7N)  
    SODIUM (UNII: 9NEZ333N27)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    ZINC (UNII: J41CSQ7QDS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24488-036-7460 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/15/2012
    Labeler - Bio 2 (961956229)
    Registrant - Creations Garden Natural Products, Inc. (961956229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Creations Garden Natural Products, Inc. 961956229manufacture
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