Label: MUSCLE RUB PAIN RELIEVER GEL- menthol, unspecified form gel

  • NDC Code(s): 52000-072-01, 52000-072-02
  • Packager: Universal Distribution Centre 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 February 21, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Menthol 2.5%

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

  • 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

    camphor, carbomer, DMDM hydantoin, isoceteth-20, isopropyl alcohol, PEG-40 hydrogenated castor oil, sodium hydroxide, water

  • Questions?

    call 1-800-223-0182 (toll-free) or 215-273-8755 (collect)

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    JOHNSON & JOHNSON
    CONSUMER INC.
    Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 57 g Tube Carton

    LabelExtra Strength Muscle Rub

    Pain Reliever Gel

    Fast Penetrating

    MENTHOL 2.5% TOPICAL ANALGESIC GEL


    NET WT 1 OZ (35.4 g)

  • INGREDIENTS AND APPEARANCE
    MUSCLE RUB PAIN RELIEVER GEL 
    menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-072
    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
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    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:52000-072-021 in 1 CARTON01/24/2021
    1NDC:52000-072-0135.4 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 finalpart34801/24/2021
    Labeler - Universal Distribution Centre LLC (019180459)
    Registrant - Anicare Pharmaceutical Pvt. Ltd. (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-072)
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