BIOCOOL FOCUS ON- 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.

----------

ACTIVE INGREDIENT

Active ingredients: Menthol 3.5%

INACTIVE INGREDIENT

Inactive ingredients:

Purified water, isopropyl alcohol, glycerin, phytoncide, peppermint oil, lavender oil, eucalyptus oil, licorice extract, methyl sulfonyl methane,
carbomer, sodium hydroxide, PEG-60 hydrogenated castor oil , methyl parahydroxybenzoate, FD & C

PURPOSE

Purpose: Topical Analgesic

WARNINGS

Warnings:

▪ Do not use the product if there are any abnormalities such as red spots, swelling or itching.

▪ Do not use the product in the areas with abnormalities such as scratches, eczema and dermatitis.

▪ Do not use the product near the eyes. In case of contact with eyes, wash immediately with water.

▪ Keep out of reach of children.

▪ After use, close the cap tightly and keep it at room temperature.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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 FOCUS ON 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70612-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol2.1 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70612-030-021 in 1 CARTON10/01/2018
1NDC:70612-030-0160 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2018
Labeler - JJindustry.Co.Ltd (689605084)
Registrant - JJindustry.Co.Ltd (689605084)
Establishment
NameAddressID/FEIBusiness Operations
JJindustry.Co.Ltd689605084manufacture(70612-030)

Revised: 11/2018
Document Id: 5531c900-e104-4e29-9211-6fa662c84b91
Set id: 913d28b5-2692-45a7-82fc-4eff713dc49b
Version: 1
Effective Time: 20181101
 
JJindustry.Co.Ltd