HAN KEE IN COOL- menthol gel 
Globalworkscompany. 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 ingredients: Menthol 2.0%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Isopropyl Alcohol, Glycerin, Camphor, Glycyrrhiza Inflata Root Extract, Methylsulfonylmethane, Carbomer, PEG-60 Hydrogenated Caster Oil, Methylparaben, Sodium Hydroxide, FD&C blue #1, Flavoring

PURPOSE

Purpose: Topical Analgesic

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

Uses

Uses:

Cool 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 Cool gel is used to help prior to the ultrasound and massage treatments.

Directions

Directions:
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

HAN KEE IN COOL 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74353-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol2.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Isopropyl Alcohol (UNII: ND2M416302)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74353-010-021 in 1 CARTON03/01/2020
1NDC:74353-010-01100 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 finalpart34803/01/2020
Labeler - Globalworkscompany. Co., Ltd. (695790020)
Registrant - Globalworkscompany. Co., Ltd. (695790020)
Establishment
NameAddressID/FEIBusiness Operations
JJindustry.Co.Ltd689605084manufacture(74353-010)

Revised: 4/2020
Document Id: 439ddc1c-4d1b-4d6c-9945-cd814f9368f1
Set id: 37cbb14e-01ef-408b-84d0-b9aa4853fb4a
Version: 1
Effective Time: 20200402
 
Globalworkscompany. Co., Ltd.