BRAZILIAN HEAT BRAZILIAN HEAT- menthol liquid 
Oxigenesis, Inc

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.

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Drug Facts

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

Warnings

Only for external use.

Flammable. Keep away from heat
or flame.


Directions

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


Keep out of reach children

product label

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)

Revised: 3/2018
Document Id: 1977c83c-6574-4998-85d3-83589f63b612
Set id: 0ec5cec8-d40b-4889-bcc8-bc7d49ed78da
Version: 1
Effective Time: 20180327
 
Oxigenesis, Inc