Label: MUSCLE RUB- menthol gel

  • NDC Code(s): 52000-020-37, 52000-020-38
  • Packager: Universal Distribution Center 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 December 13, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient

    Menthol 2.5%

  • PURPOSE

    Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses

    • Provides soothing relief of minor arthritis pain, aching muscles, joints and backaches.
  • WARNINGS

    Warnings

    For external use only. Use only as directed. Keep out of reach of children to avoid accidental poisoning.

    • Avoid contact with eyes or mucous membranes.
    • Discontinue use if excessive irritation of the skin develops.
    • Do not bandage tightly, apply to wounds, broken or irritated skin, or use with a heating pad.
    • If condition worsens, or if symptoms persist for more than 10 days or clear-up and occur again within a few days, if skin redness or irritation develops, discontinue use of this product and consult a doctor.
    • For arthritis like conditions in children under 12, do not use. Consult a doctor.
  • KEEP OUT OF REACH OF CHILDREN

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily and gently massage until gel disappears.
    • Children under 12 years of age: do not use, consult a doctor
  • SPL UNCLASSIFIED SECTION

    Other Information

    • Store at controlled room temperature 15°C to 30°C (59°F to 86°F)
    • Lot No. & Exp. Date: see crimp of tube.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Camphor, Carbomer, DMDM Hydantoin, Isoceteth, Isopropyl Alcohol, PEG-40 Hydrogenated Castor Oil, Sodium Hydroxide, Water

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    MUSCLE RUB GEL

    NET WT 1.25 OZ (35 g)

    image of package label

  • INGREDIENTS AND APPEARANCE
    MUSCLE RUB 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.025 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-020-371 in 1 BOX12/13/2020
    1NDC:52000-020-3835 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 finalpart34804/15/2015
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-020)