MUSCLE AND JOINT (MENTHOL, UNSPECIFIED FORM) GEL [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]

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  • MUSCLE AND JOINT (MENTHOL, UNSPECIFIED FORM) GEL [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]

MUSCLE AND JOINT (MENTHOL, UNSPECIFIED FORM) GEL [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]
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NDC 50382-016-15
Set ID f15424c2-ce5c-463d-a674-1440a7cc3709
Category HUMAN OTC DRUG LABEL
Packager Galentic Pharma (India) Private Limited
Generic Name
Product Class
Product Number
Application Number PART348
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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)
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