Label: QUALITY CHOICE MUSCLE AND JOINT- 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 September 16, 2011

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  • Active ingredient

    Menthol 2.5%

  • Uses

    • For the timporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis and sprains
  • Warnings

    For external use only.

    • DO NOT USE WITH A HEATING PAD
    • DO NOT BANDAGE TIGHTLY
    • DO NOT SWALLOW
    • If swallowed, induce vomiting and call a physician. Keep away from eyes, mucous membranes, broken or irritated skin. If redness or irritation develops, pain lasts more than 10 days or with arthritis-like conditions in children under 12, do not use and call a physician.

    KEEP AWAY FROM CHILDREN TO AVOID ACCIDENTAL POISONING.

    Enter section text here

  • Directions

    • Apply generously and gently massage until gel disappears
    • Repeat 3 to 4 times daily
    • Relief lasts for hours
    For best results, squeeze tube from the bottom and flatten as you use product
  • Other information

    • store between 15° - 30°C (59° to 86°F)
  • Inactive ingredients

    camphor, carbomer 940, potassium sorbate, isoprophyl alcohol, methylparaben, polysorbate 60, purified water, and trolamine

  • Package label

    QC Muscle and Joint Vanishing Scent Gelimage of carton label

  • Purpose

    External analgesic

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE MUSCLE AND JOINT 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-013
    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)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    isopropyl alcohol (UNII: ND2M416302)  
    methylparaben (UNII: A2I8C7HI9T)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    water (UNII: 059QF0KO0R)  
    trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-013-021 in 1 BOX
    157 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/16/2011
    Labeler - Chain Drug Marketing Association (011920774)
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