BIOCOOL TUBE TYPE- menthol gel 
JJindustry.Co.Ltd

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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ACTIVE INGREDIENT

Active Ingredient: Menthol 4%

INACTIVE INGREDIENT

Inactive Ingredients: Purified Water, Isopropyl Alcohol, Camphor, Glycerin, Glycyrrhiza Glabra Root Extract, Methyl sulfonyl methane, Carbomer, PEG-60 Hydrogenated Caster Oil, Methylparaben, Sodium Hydroxide, FD&C blue #1(CI42090), Flavoring.

PURPOSE

Purpose: BIOCOOL Sports Gel is specially formulated for the temporary activation from muscle and joint stiffness through cooling and refreshing effect. It is patented for the formulation, which contains Menthol, Camphor, and Glycyrrhiza Glabra Root Extract, Methyl sulfonyl methane. Patient response to ultrasound and sports massage therapy is enhanced when BIOCOOL Sports Gel is used to help prior to the ultrasound and massage treatments.

WARNINGS

Warnings: Use only as directed. For external use only. Avoid contact with the eyes. Do not apply to wounds or damaged skin. Do not apply to irritated skin or if excessive irritation develops. Store at room temperature with lid closed tightly. Keep away from excessive heat or open flame. Do not use with heating pads or devices.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help immediately.

Usages

Usages: For the activation of muscle and joint. For use with ultrasonic transmission treatments and sports massage. Apply appropriate amount onto affected area and rub until fully absorbed. It's more effective when applied 2~3 times repeatedly.

Usages

Usages: For the activation of muscle and joint. For use with ultrasonic transmission treatments and sports massage. Apply appropriate amount onto affected area and rub until fully absorbed. It's more effective when applied 2~3 times repeatedly.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

BIOCOOL  TUBE TYPE
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70612-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol4.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70612-010-021 in 1 CARTON03/02/2016
1NDC:70612-010-01100 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/02/2016
Labeler - JJindustry.Co.Ltd (689605084)
Registrant - JJindustry.Co.Ltd (689605084)
Establishment
NameAddressID/FEIBusiness Operations
JJindustry.Co.Ltd689605084manufacture(70612-010)

Revised: 4/2016
Document Id: 3a3614d6-ca20-4556-b768-6e1598e6aa0b
Set id: dd430130-eb92-47fc-a113-a1a90d169810
Version: 1
Effective Time: 20160419
 
JJindustry.Co.Ltd