Label: BIOCOOL FOCUS ON- menthol gel

  • NDC Code(s): 70612-030-01, 70612-030-02
  • Packager: JJindustry.Co.Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 November 1, 2018

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  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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