Label: MUSCLE AND JOINT- menthol, unspecified form gel

  • NDC Code(s): 50382-016-15
  • Packager: Galentic Pharma (India) Private Limited
  • 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 November 27, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • • ACTIVE INGREDIENT

    Menthol 2.5%

  • • PURPOSE

    Topical Analegesic

  • • USES

    For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains, and bruises

  • • WARNINGS

    For External Use Only.

    Do not use

    • On wounds or damaged skin
    • With a heating pad
    • On children under 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

    Keep out of Reach of Children. If swallowed, get medical help of contact a Poison Control Center immediately.

  • • DIRECTIONS

    • Adults 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 15° to 30°C (59° to 86°F)
  • • INACTIVE INGREDIENT

    Camphor, Carbomer 980, Isopropyl alcohol, Methylparaben, Polysorbate 60, Potassium Sorbate, Trolamine, Purified water

  • SPL UNCLASSIFIED SECTION

    Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone,

    Gandhidham-370 230, Gujarat. India

  • PRINCIPAL DISPLAY PANEL 85 g Tube Carton

    Galentic

    Muscle & Joint
    VANISHING SCENT GEL

    Quick Relief

    NET WT.
    3 OZ. (85g)

    PRINCIPAL DISPLAY PANEL 85 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    MUSCLE AND JOINT 
    menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50382-016-151 in 1 CARTON06/01/2012
    185 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 finalpart34806/01/2012
    Labeler - Galentic Pharma (India) Private Limited (915110464)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic Pharma (India) Private Limited650970176analysis(50382-016) , manufacture(50382-016) , pack(50382-016) , repack(50382-016) , sterilize(50382-016)