Label: PERSONAL CARE ICE COLD ANALGESIC- menthol gel

  • NDC Code(s): 72133-210-08
  • Packager: Delta Brands & Products LLC
  • 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 April 17, 2018

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  • Active ingredient

    Menthol 1.25%

  • Purpose


    Topical Analgesic

  • Uses

    ■ temporarily relieves minoraches and pains of muscles and joints associated with:

    ■ arthritis ■ simple backache ■ strains ■ bruises ■ sports injuries ■ sprains ■ ​provides cooling penetrating relief

  • Warnings

    For external use only

  • Do not use

    ■ with other topical relievers ■ with heating pads or heating devices

  • When using this product

    ■ do not use in or near the eyes ■ do not apply to wounds or damaged skin ■ do not bandage tightly

  • Stop use and ask a doctor if

    ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days ■ redness or irritation develops

  • Keep out of reach of children

    If pregnant or breast-feeding, ask a health professional before use. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ clean affected area before applying product ■ adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily ■ children under 2 years of age: ask a doctor

  • Other information

    ■ stroe at controlled room temperature 20 to 25 ºC (68 to 77ºF) in a tightly closed container ■ do not use, pour, spill or store near heat or open flame

  • Inactive Ingredients

    benzyl alcohol, BHT, camphor, carbopol, disodium EDTA, FD&C blue no. 1, isopropyl alcohol, PEG-40 hydrogenated castor oi, propylene glycol, sodium hydroxide, water

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE  ICE COLD ANALGESIC
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72133-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72133-210-08227 g in 1 JAR; Type 0: Not a Combination Product04/02/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/02/2018
    Labeler - Delta Brands & Products LLC (080999173)
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