BRAZILIAN HEAT BRAZILIAN HEAT- menthol liquid

Brazilian Heat by

Drug Labeling and Warnings

Brazilian Heat by is a Otc medication manufactured, distributed, or labeled by Oxigenesis, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

BRAZILIAN HEAT  BRAZILIAN HEAT
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72136-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72136-001-01	60 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	03/27/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/27/2018

Labeler - Oxigenesis, Inc (006774725)

Registrant - Oxigenesis, Inc (006774725)

Establishment
Name	Address	ID/FEI	Business Operations
Oxigenesis, Inc		006774725	manufacture(72136-001)