QUALITY CHOICE MUSCLE AND JOINT (MENTHOL) GEL [CHAIN DRUG MARKETING ASSOCIATION]

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QUALITY CHOICE MUSCLE AND JOINT (MENTHOL) GEL [CHAIN DRUG MARKETING ASSOCIATION]
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NDC 63868-013-02
Set ID 0d8f2d13-3ce5-4ac7-afaf-c57f38ba4b62
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Marketing Association
Generic Name
Product Class
Product Number
Application Number PART348
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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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