Label: HAN KEE IN COOL- menthol gel

  • NDC Code(s): 74353-010-01, 74353-010-02
  • Packager: Globalworkscompany. Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated April 2, 2020

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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

  • INGREDIENTS AND APPEARANCE
    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)