Label: 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 27, 2018

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  • Active Ingredient

    Active Ingredient
    Menthol 7.0%


  • Inactives

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

  • Purpose

    Purpose
    External analgesic

  • 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.

  • Directions

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


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach children

  • PRINCIPAL DISPLAY PANEL

    product label

  • INGREDIENTS AND APPEARANCE
    BRAZILIAN HEAT  BRAZILIAN HEAT
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72136-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol70 mg  in 1 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:72136-001-0160 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product03/27/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/27/2018
    Labeler - Oxigenesis, Inc (006774725)
    Registrant - Oxigenesis, Inc (006774725)
    Establishment
    NameAddressID/FEIBusiness Operations
    Oxigenesis, Inc006774725manufacture(72136-001)
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