MUSCLE RUB (MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]

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  • MUSCLE RUB (MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]

MUSCLE RUB (MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]
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NDC 50382-015-15
Set ID abf1161c-e51b-4cae-9294-900a50a59b7f
Category HUMAN OTC DRUG LABEL
Packager Galentic Pharma (India) Private Limited
Generic Name
Product Class
Product Number
Application Number PART348
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  • • ACTIVE INGREDIENT

    Menthol 10%

    Methyl Salicylate 15%

  • • PURPOSE

    Topical analgesic

  • • USES

    Temporarily relieves the minor aches and pains of muscles and joints associated with

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains.
  • • WARNINGS

    For external use only

    Do not use

    • On wounds or damaged skin
    • With a heating pad
    • On a child 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 membrane
    • 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 to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

  • • DIRECTIONS

    • Use only as directed
    • Adults and children 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 at 15° to 25 °C (59° to 77°F)
    • Lot No. & Exp. Date : See box or see crimp of tube
  • • INACTIVE INGREDIENTS

    Citric Acid, Glyceryl Monostearate, Lanolin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Polysorbate 80, Stearic Acid, Trolamine

  • 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 Rub
    ULTRA STRENGTH

    Pain Relieving Cream
    Non-Greasy

    NET WT.
    3 OZ. (85g)

    PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    MUSCLE RUB 
    menthol, unspecified form and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE150 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LANOLIN (UNII: 7EV65EAW6H)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50382-015-151 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(50382-015) , manufacture(50382-015) , pack(50382-015) , repack(50382-015) , sterilize(50382-015)
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