Label: PAIN RELIEF COLD THERAPY GEL 3 FL OZ- menthol 4% gel 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 December 31, 2022

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

View All Sections
  • Active Ingredient

    Menthol 4%

  • Purpose

    Cooling Pain Relief

  • Uses

    Temporary relief from minor aches and pains of sore muscles and
    joints associated with •arthritis •backache •strains •sprains

  • Warnings

    For external use only

    Flammable

    Keep away from excessive heat or open flame

    Ask a doctor before use if you have

    sensitive skin

    When using this product

    • avoid contact with the eyes or mucous membranes

    • do not apply to wounds or damaged skin

    • do not use with other ointments, creams, sprays or liniments

    • do not apply to irritated skin or if excessive irritation develops

    • do not bandage

    • wash hands after use with cool water

    • do not use with heating pad or device

    Stop use and ask a doctor if

    condition worsens, or if symptoms persist for more than 7 days, or clear up and recur

    If pregnant or breast-feeding

    ask a health professional before use

    Keep out of reach of Children.

    If accidentally ingested, get medical help or contact a Poison Control Center (1-800-222-1222) immediately

  • Directions

    • Adults and children 2 years of age and older: rub a thin film over affected areas not more than 4 times daily, massage not necessary

    • Children under 2 years of age: consult physician

  • Other Information

    • store in a cool dry place

  • Inactive ingredients

    aloe vera gel, arnica montana flower extract, articum lappa root (burdock) extract, boswellia carterii resin extract, calendula officinalis extract, camellia sinensis (green tea) leaf extract, camphor, carbomer 934, colloidal silicon dioxide, FD&C blue no.1, FD&C yellow no.5, glycerin, ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, melissa officinalis (lemon balm) leaf extract, purified water, sorbic acid, tocopheryl acetate, triethanolamine

  • Questions or comments

    1-856-357-7321

  • Pain Relief Cold Therapy Gel 3 FL OZ

    Cold Therapy Gel 3 FL OZ

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF COLD THERAPY GEL 3 FL OZ 
    menthol 4% gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72351-641
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CARBOMER 934 (UNII: Z135WT9208)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    BRILLIANT BLUE G (UNII: M1ZRX790SI)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SORBIC ACID (UNII: X045WJ989B)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72351-641-0388.72 mL in 1 TUBE; Type 0: Not a Combination Product04/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2021
    Labeler - SOTAC PHARMACEUTICAL PRIVATE LIMITED (876894019)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sotac Pharmaceutical Private limited876894019label(72351-641) , analysis(72351-641) , manufacture(72351-641)
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!