BIO 2 BRAZILIAN HEAT BRAZILIAN HEAT- menthol liquid 
Bio 2

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%


Purpose

Purpose
External analgesi

Use

Warnings

Only for external use.

Flammable. Keep away from heat
or flame.


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.


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.

Placeholder Text

Bio 2 Brazilian Heat

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

Revised: 3/2012
Document Id: f119c979-2cfc-471d-91df-98a6cf4504fd
Set id: aa5540fe-a857-40f8-8d2e-2940e3f6d112
Version: 1
Effective Time: 20120315
 
Bio 2