Label: BIOCOOL ROLL TYPE- menthol gel

  • NDC Code(s): 70612-020-01, 70612-020-02
  • 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 April 19, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient: Menthol 4%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Purified Water, Isopropyl Alcohol, Camphor, Glycerin, Glycyrrhiza Glabra Root Extract, Methyl sulfonyl methane, Carbomer, PEG-60 Hydrogenated Caster Oil, Methylparaben, Sodium Hydroxide, FD&C blue #1(CI42090), Flavoring.

  • PURPOSE

    Purpose: BIOCOOL Sports 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 BIOCOOL Sports Gel is used to help prior to the ultrasound and massage treatments.

  • 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 to avoid accidental ingestion. If swallowed, get medical help immediately.

  • 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  ROLL TYPE
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70612-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol4.0 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70612-020-021 in 1 CARTON03/02/2016
    1NDC:70612-020-01100 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 finalpart34803/02/2016
    Labeler - JJindustry.Co.Ltd (689605084)
    Registrant - JJindustry.Co.Ltd (689605084)
    Establishment
    NameAddressID/FEIBusiness Operations
    JJindustry.Co.Ltd689605084manufacture(70612-020)