Label: MUSCLE AND JOINT VANISHING SCENT FAST PENETRATING- 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 August 23, 2010

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  • Muscle and Joint Vanishing Scent (Fast Penetrating)

    Active Ingredients

    Menthol 2.5%

  • PURPOSE

    Purpose

    External Analgesic

  • WARNINGS

    Warnings

    For external use only

    • DO NOT USE WITH A HEATING PAD
    • KEEP AWAY FROM CHILDREN TO AVOID ACCIDENTAL POISONING
    • DO NOT BANDAGE TIGHTLY
    • DO NOT SWALLOW
    • If swallowed, induce vomiting and call a physician.
    • Keep away from eyes and mucous membranes
    • Do not apply to wounds or broken, damaged or irritated skin.
    • If condition worsens, skin redness or irritation develops, or pain lasts more than 7 days, discontinue use and call a physician
    • For arthritis-like conditions in children under 12, do not use and call a physician.
  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 2 years of age and older

    • Apply generously and gently massage until gel disappears
    • Repeat up to 3 to 4 times daily
    • For best results, squeeze tube from the bottom and flatten as you use product.
    Children under 2 years of age: consult a physician
  • STORAGE AND HANDLING

    Other information

    Store between 15oC - 30oC (59oF-86oF)

    Lot No. and Exp. Date: see box or see crimp of tube

  • INACTIVE INGREDIENT

    Inactive Ingredients

    carbomer 940, dl-camphor, isopropanol, methylparaben, potassium sorbate, polysorbate 60, purified water, stearyl alcohol, trolamine

  • QUESTIONS

    Questions?

    Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.

  • INDICATIONS & USAGE


    Uses

    • For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis and sprains
  • KEEP OUT OF REACH OF CHILDREN


    KEEP AWAY FROM CHILDREN TO AVOID ACCIDENTAL POISONING


  • PRINCIPAL DISPLAY PANEL


    Image of Carton Label

    Image of Tube Label

  • INGREDIENTS AND APPEARANCE
    MUSCLE AND JOINT VANISHING SCENT  FAST PENETRATING
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51852-104
    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 Homopolymer Type C (UNII: 4Q93RCW27E)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Water (UNII: 059QF0KO0R)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Trolamine (UNII: 9O3K93S3TK)  
    Camphor (Synthetic) (UNII: 5TJD82A1ET)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51852-104-011 in 1 CARTON
    157 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/01/2010
    Labeler - LIFElabs, a Division of Atico International USA, INC. (073876450)