BIOCOOL FOCUS ON- menthol gel

Biocool Focus On by

Drug Labeling and Warnings

Biocool Focus On by is a Otc medication manufactured, distributed, or labeled by JJindustry.Co.Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

BIOCOOL FOCUS ON 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70612-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	Menthol	2.1 g  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70612-030-02	1 in 1 CARTON	10/01/2018
1	NDC: 70612-030-01	60 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/01/2018

Labeler - JJindustry.Co.Ltd (689605084)

Registrant - JJindustry.Co.Ltd (689605084)

Establishment
Name	Address	ID/FEI	Business Operations
JJindustry.Co.Ltd		689605084	manufacture(70612-030)