BIO 2 BRAZILIAN HEAT BRAZILIAN HEAT- menthol liquid

Bio 2 Brazilian Heat by

Drug Labeling and Warnings

Bio 2 Brazilian Heat by is a Otc medication manufactured, distributed, or labeled by Bio 2, Creations Garden Natural Products, Inc. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

BIO 2 BRAZILIAN HEAT  BRAZILIAN HEAT
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24488-036
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	4.2 mL  in 60 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: 24488-036-74	60 mL in 1 BOTTLE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/15/2012

Labeler - Bio 2 (961956229)

Registrant - Creations Garden Natural Products, Inc. (961956229)

Establishment
Name	Address	ID/FEI	Business Operations
Creations Garden Natural Products, Inc.		961956229	manufacture