MAKESENSE EXTRA STRENGTH MUSCLE RUB (MENTHOL) GEL [CHERRY HILL SALES CO]

MAKESENSE EXTRA STRENGTH MUSCLE RUB (MENTHOL) GEL [CHERRY HILL SALES CO]
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NDC 69020-200-15
Set ID 1fecf16e-f676-4fbb-b2d5-79a0b0b5a526
Category HUMAN OTC DRUG LABEL
Packager Cherry Hill Sales Co
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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