Label: COLD SPOT POINT RELIEF- menthol swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 October 14, 2011

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

View All Sections
  • ACTIVE INGREDIENT

    menthol - usp 12%

  • INACTIVE INGREDIENT

    aqua (deionized water), arnica montana flower (arnica) extract, chondroitin sulfate, citric acid, eucalyptus globulus oil, glucosamine sulfate,ilex paraguariensis leaf (yerba mate) extract, isopropyl alcohol, menth piperita (pepperment) oil, MSM (dimethyl sulfone) polysorbate-20, SD-alcohol 40B, triethanolamine

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, consult physician.

  • WARNINGS

    for external use only

    avoid contact with eyes

    do not apply to open wounds or damaged skin

    if symptoms persist for more than seven days, discontinue use and consult physician

    keep out of reach of children. if swallowed, consult physician

    do not bandage tightly

  • INDICATIONS & USAGE

    for temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprains.

  • DOSAGE & ADMINISTRATION

    wipe onto affected area. discard wipe and clean hands after use. do not use more than four times per day.

  • PURPOSE

    For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprains.

  • PRINCIPAL DISPLAY PANEL

    cold spot point relief wipes


    carton image

    carton image

  • INGREDIENTS AND APPEARANCE
    COLD SPOT  POINT RELIEF
    menthol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51452-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol.96 mL  in 8 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
    BROMELAINS (UNII: U182GP2CF3)  
    alcohol (UNII: 3K9958V90M)  
    Eucalyptus Globulus leaf (UNII: S546YLW6E6)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Dimethyl Sulfone (UNII: 9H4PO4Z4FT)  
    Chondroitin sulfate (bovine) (UNII: 6IC1M3OG5Z)  
    Citric Acid (UNII: 2968PHW8QP)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    polysorbate 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51452-004-008 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/13/2011
    Labeler - Fabrication Enterprises, inc. (070577218)
    Registrant - Pure Source (969241041)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source 969241041manufacture
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!