Label: VANISHING SCENT MUSCLE RUB GEL- menthol gel

  • 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 December 28, 2016

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  • Drug Facts

  • Active ingredient

    Menthol 2.5%

    Purpose

    Topical analgesic

  • Uses

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

  • Warnings

    For external use only.

    Do not use

    • on wounds or damaged skin • with a heating pad • on a child 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

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily • children under 12 years of age: ask a doctor

  • Other information

    • Store between 20 C and 25 C (68 F and 77 F) • Lot No. & Exp. Date. see box or crimp of tube

  • Inactive ingredients

    CARBOMER 940, DL-CAMPHOR, ISOPROPANOL, METHYLPARABEN, POLYSORBATE 60, POTASSIUM SORBATE, PURIFIED WATER, STEARYL ALCOHOL, TROLAMINE

  • Product Label

    MUSCLE RUB

  • INGREDIENTS AND APPEARANCE
    VANISHING SCENT MUSCLE RUB GEL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52486-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52486-012-571 in 1 CARTON03/27/2015
    157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/27/2015
    Labeler - McCure Health Solutions Inc. (053034873)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangsu Dedi Medical Device Co., Ltd.544458936manufacture(52486-012)
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