Label: QUALITY CHOICE COLD THERAPY GEL- menthol gel

  • NDC Code(s): 83324-007-04
  • Packager: Chain Drug Marketing Association, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 25, 2024

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  • 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 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 a heating pad or device

    Stop use an ask a doctor if

    condition worsens, if symptoms last more than 7 days or clear up and reoccur

    If pregnant or breastfeeding:

    ask a health professional before use

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

  • Directions

    adults and children 2 years of age and older:

    • rub a thin film over affected area not more than 4 times daily, massage is not necessary

    children under 2 years of age: consult a physician

  • Other Info

    ■ store in a cool dry place
    ■ do not use if tube seal under cap is broken

  • Inactive Ingredients

    Inactive ingredients

    benzyl alcohol, butylated hydroxytoluene, camphor, carbopol 940, edetate disodium, DMDM hydantoin, FD&C blue no. 1, FD&C yellow no. 5,isopropyl alcohol, PEG-40 hydrogenated castor oil, sodium hydroxide, water

  • Uses

    Temporarily relieves minor aches and pains of muscles and joints associated with:

    • arthritis
    • backache
    • strains
    • sprains
  • Active ingredient

    Menthol 4%

  • Purpose

    Topical analgesic

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE COLD THERAPY GEL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-007
    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
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    WATER (UNII: 059QF0KO0R)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83324-007-04118.2 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/01/2023
    Labeler - Chain Drug Marketing Association, Inc. (011920774)
    Establishment
    NameAddressID/FEIBusiness Operations
    Astonea Labs Private Label878533295manufacture(83324-007)
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