Label: ASTONEA COLD THERAPY- menthol 4% gel

  • NDC Code(s): 77338-007-04
  • Packager: ASTONEA LABS PRIVATE LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 12, 2024

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  • ACTIVE INGREDIENT

    Menthol 4%

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    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

    Stop use and ask a doctor if

    condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

    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 alter use with cool water ■do not use with heating pad or device

    If pregnant or breastfeeding, ask a health professional before use

    Keep out of reach of children: If accidentally ingested, get medical help or contact a poison Control immediately (1800-222-1222)

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 2 years of age and older:Rub a thin film over affected areas not more than daily: massage not necessary

    Children under 2 years of age :Consult physician

  • INACTIVE INGREDIENT

    camphor, carbopol 940, DMDM hydantoin, edetate disodium, FD&C yellow no. 5, FD&C blue no. 1, isopropyl alcohol, PEG 40

    hydrogenated castor oil, propylene glycol, sodium hydroxide, water

  • PRINCIPAL DISPLAY PANEL

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    ASTONEA COLD THERAPY 
    menthol 4% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77338-007-04118.2 g in 1 TUBE; Type 0: Not a Combination Product03/12/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/12/2024
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
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