Label: TOPICOOL PAIN RELIEF WITH CATS CLAW- menthol gel

  • 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

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

View All Sections
  • Active Ingredients:

    Camphor 0.4%

    Menthol 4.5%

  • Purpose:

    External Analgesic

    External Analgesic

  • Uses:

    For the temporary relief of

    • arthritis
    • backache
    • sprains
    • strains
  • Warnings:

    Use only as directed.
    For external use only.

    Do not use

    • with other topical products
    • on open wounds or damaged skin

    Ask a doctor or pharmacist if you are

    pregnant or breastfeeding

    Stop use and consult a doctor if

    symptoms persist for more than 7 days


    Avoid contact with eyes
    Do not bandage tightly
    Keep away from excessive heat or open flame

    KEEP OUT OF REACH OF CHILDREN.

    In case of ingestion, seek professional assistance and contact poison control immediately.

  • Directions:

    • Adults and children 2 years of age and older apply to affected area not more than 4 times daily
    • rub in thoroughly until gel is absorbed
  • Other information:

    Store at room temperature with cap closed.

  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aqua (Deionized Water), Boswellia Serrata Extract, Ethylhexylglycerin, Glycerin, Ilex Paraguariensis (Yerba Mate) Extract, Isopropyl Alcohol, Phenoxyethanol, Polysorbate-20, Propylene Glycol, Tetrasodium EDTA, Triethanolamine, Uncaria Tomentosa (Cat's Claw) Extract, Zemea Propanediol

  • Questions or Comments?

    (866) 449-1010 or www.tensproducts.com

  • PRINCIPAL DISPLAY PANEL - 85.049 g Tube Label

    TopiCool™
    Pain relief gel with Cat's Claw

    NET WT 3 OZ (85.049g)

    Principal Display Panel - 85.049 g Tube Label
  • INGREDIENTS AND APPEARANCE
    TOPICOOL PAIN RELIEF  WITH CATS CLAW
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57698-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM4.5 g  in 100 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)0.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    WATER (UNII: 059QF0KO0R)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CAT'S CLAW (UNII: 9060PRM18Q)  
    TRIMETHYLOLPROPANE (UNII: 090GDF4HBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57698-100-0385.049 g in 1 TUBE; Type 0: Not a Combination Product08/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/2013
    Labeler - TENSproducts, Inc. (121251883)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!