Label: PAIN RELIEVER- menthol gel

  • 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 August 24, 2011

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  • WARNINGS

    Warnings:

    For external use only.
    Do not use on wounds or damaged skin
    When using this product: use only as directed. Avoid contact with eyes. Do no bandage tightly
    Stop use and ask a doctor if: redness is present. Irritation develops. Condition worsens or symptoms persist more than 7 days. Symptoms clear up and occur again within a few days.
    Store at room temperature. Lot number and expiration date see crimp or see box.
  • DOSAGE & ADMINISTRATION

    Directions:

    Adults and children over 12 year. Apply generous amount directly to affected area. Massage into painful area until thoroughly absorbed into skin. Repeat as necessary, but no more that 4 times daily.
  • INACTIVE INGREDIENT


    INACTIVE INGREDIENTS:
    Water. Ethanol. PPG-26 Buteth-26 (and) PEG-40. Hydrogenated Castor Oil. Acrylates/C10-30 alkyl acrylate crosspolymer. Triethanolamine. Glucosamine Sulfate. Methyl Sulfonyl Methane. (MSM). Bromelain. Harpagophytum procumbens (Devil's Claw). Hippocastanaceae aesculus hippocastanum (Horse Chestnut). Rosmarinus officinalis. Aloe barbadenis miller. Chamaemelum nobile. Capsicum annuun Extract. Tilia cordata Extract (Linden flower). Melissa officinalis. Arnica montana. Saliz alba. Eucalyptus globoulus. Tocopheryl acetate. Phenoxyethanol Ethylhexyglycerin. Potassium Sorbate. EDTA. FD and C Green # 3. FD and C Yellow # 10
  • PURPOSE

    Uses for temporary relief of minor aches and pains of muscles and joint associated with: simple aches, back aches, arthritis, strains, bruises, sprains.

  • ACTIVE INGREDIENT

    Menthol 2% Topical analgesic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a Posion Control Center immediately.
  • INDICATIONS & USAGE

    Enter section text here

  • PRINCIPAL DISPLAY PANEL

    Image of MM1
  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.4 g  in 120 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHANOL (UNII: 3K9958V90M)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    BROMELAINS (UNII: U182GP2CF3)  
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)  
    ALOE FEROX LEAF (UNII: 0D145J8EME)  
    CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)  
    CAPSICUM (UNII: 00UK7646FG)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    MELISSA OFFICINALIS (UNII: YF70189L0N)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    SALIX ALBA LEAF (UNII: M7S08QZ9JA)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35192-002-02120 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/24/2011
    Labeler - CA-BOTANA INTERNATIONAL (106276728)
    Registrant - RODOLFO UGELSTAD (106276728)
    Establishment
    NameAddressID/FEIBusiness Operations
    CA-BOTANA INTERNATIONAL106276728manufacture
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