Label: PAIN RELIEVING ANALGESIC- menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 20, 2012

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  • Active Ingredients

    Menthol 2%

  • Purpose

    Topical Analgesic

  • Uses

    For temporary relief of minor aches and muscles pain: simple back aches, sprains and strains common to sports activities, joint pains associated with arthritis.

  • Directions

    Clean skin of all other lotions, creams, ointments, liniments: Apply liberally to affected area and massage until gel is absorbed into skin. Do not apply more than 3 or 4 times within a 24 hour period. No protective cover needed. Do not apply to children under 2 years of age.

  • Warnings

    Use only as directed.

    Keep out of reach of children.

    For external use only. If swallowed contact a physician or poison control center immediately. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Make sure skin is clean and free of any creams ointments, sprays or liniments. Do not cover with bandage.

    Do not use

    with heating pads or heating devices.

    Discontinue use and consult a physician if skin irritation develops, condition recurs, worsens or symptoms persist for more that 7 days. Consult your doctor before use if you are pregnant or nursing. Do not use, pour, spill or store near heat or open flame. Store in a cool, dry place. Keep lid tightly closed.

  • Inactive Ingredients

    Water, Isopropyl Alcohol, Nonoxynol-10, Camphor, Carbomer, Sodium Hydroxide, Methylchloroisothiazolinone & Mathylisothiazolinone, FD&C Blue #1.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL
    elizabeth style
    Therapeutic, Greaseless
    Fast, temporary relief from minor aches and pains
    Blue Ice
    Net Wt. 8 Oz (227 g)
    PAIN RELIEVING ANALGESIC GEL
    PRINCIPAL DISPLAY PANEL - 8 oz

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING ANALGESIC 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52920-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.54 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER 934 (UNII: Z135WT9208)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52920-123-03227 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34109/21/2009
    Labeler - Singhfam Corporation (019499958)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd.916837425MANUFACTURE(52920-123)
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