MUSCLE AND JOINT VANISHING SCENT FAST PENETRATING (MENTHOL) GEL [LIFELABS, A DIVISION OF ATICO INTERNATIONAL USA, INC.]

MUSCLE AND JOINT VANISHING SCENT FAST PENETRATING (MENTHOL) GEL [LIFELABS, A DIVISION OF ATICO INTERNATIONAL USA, INC.]
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NDC 51852-104-01
Set ID 905152c2-aa08-4187-87f4-f47f5468041f
Category HUMAN OTC DRUG LABEL
Packager LIFElabs, a Division of Atico International USA, INC.
Generic Name
Product Class
Product Number
Application Number PART348
  • 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)

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