Label: MUSCLE RUB- menthol, unspecified form and methyl salicylate cream

  • NDC Code(s): 50382-015-15
  • 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.

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Updated November 28, 2022

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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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LANOLIN (UNII: 7EV65EAW6H)  
    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) , sterilize(50382-015)
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