Label: MUSCLE RUB- menthol gel

  • NDC Code(s): 80489-004-01, 80489-004-02
  • Packager: OL PHARMA TECH,LLC
  • 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 October 2, 2023

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  • ACTIVE INGREDIENT

    MENTHOL 2.5%

  • PURPOSE

    TOPICAL ANALGESIC

  • USES

    temporarily relieves the minor aches and pains of muscles and joints associated with:

    • simple backaches
    • arthritis
    • strains
    • bruises
    • sprains
  • WARNINGS

    For external use only

  • Do not use

    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 membranes
    • do not bandage tightly
  • Stop use and ask your doctor

    Stop use and ask your 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 or contact a Poison Control Center immediately.

  • Directions

    • 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 20° to 25°C (68° to 77°F)

  • Inactive Ingredients


    vitamin E, propylene glycol, polysorbate 80, water, isopropyl alcohol, carbomer interpolymer type A, EDTA , methylparaben, propylparaben

  • Questions

    www.drspharmacyusa.com

  • PRINCIPAL DISPLAY PANEL

    • original strenghth
    • Topical analgesic
      muscle rub
  • INGREDIENTS AND APPEARANCE
    MUSCLE RUB 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80489-004
    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
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Product Characteristics
    Colorwhite (TRANSLUCENT) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80489-004-011 in 1 CARTON01/01/2021
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:80489-004-021 in 1 CARTON01/01/2021
    249.6 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 finalpart34801/01/2021
    Labeler - OL PHARMA TECH,LLC (021170377)
    Registrant - OL PHARMA TECH,LLC (021170377)
    Establishment
    NameAddressID/FEIBusiness Operations
    OL PHARMA TECH,LLC (Drs. pharmacy)021170377manufacture(80489-004)
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