Label: MAKESENSE EXTRA STRENGTH MUSCLE RUB- menthol gel

  • Category: HUMAN OTC DRUG LABEL

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 June 13, 2014

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  • Active Ingredients

    Menthol 2.5%

  • Purpose

    Topical Analgesic

  • Uses

    ■ temporarily relieves the minor arthritis pains of muscles and joints associated with ■ simple backache ■ bruises ■arthritis ■strains ■sprains

  • Warnings

    For external use only. Flammable: Keep away from fire or flame

  • Do not use

    ■ on wounds or damaged skin ■ with a heating pad ■ on a child under 12 years of age with arthritis like conditions

  • Ask a doctor before use

    ■ if you have redness over the affected area

  • When using this product

    ■ avoid contact with eyes or mucous membranes. ■ do not bandage tightly

  • Stop use and ask a doctor if

    ■ condition worsens, or symptoms persist for more than 7 days ■ symptoms clear-up and occur again within a few days, ■excessive skin irritation occurs ■ you have redness over the affected area

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    ■ adults and children12 years of age and older: apply to affected area not more than 3-4 times 

    ■ children under 12 years of age: ask a doctor

  • Other information

    ■ store at room temperature 20 to 25C (68 to 77F)

  • Inactive Ingredients

    Camphor, Carbomer, DMDM Hydantoin, Isoceteth, Isopropyl Alcohol, PEG-40 Hydrogenated Castor Oil, Sodium Hydroxide and Water

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    MAKESENSE  EXTRA STRENGTH MUSCLE RUB
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69020-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69020-200-1542.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2014
    Labeler - Cherry Hill Sales Co (145959768)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.529836561manufacture(69020-200)
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