Label: LONOL FORTE GEL- methyl salicylate, menthol, capsaicin 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 June 28, 2019

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

  • Drug Facts

  • Active Ingredients

    Methyl Salicylate 20%

    Menthol 10%

    Capsaicin 0.002%

  • Purpose

    Topical Analgesic

  • Uses:

    For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains, strains, and bruises.

  • Warnings:

    For external use only.

    Do not use if you are allergic to any of the active or inactive ingredients.

    Do not use: on wounds damaged, broken, or irritated skin. With a heating pad. Immediately before or after taking a bath or shower.

    Stop use and ask a doctor if: Condition worsens. Symptoms persist for more than 7 days or clear up and occur again within a few days. Skin irritation occurs.

    When using this product, do not: heat, microwave, add to hot water or any container with heating water. May cause splattering and results in burns. Avoid contact with lips, eyes, nose, and any mucous membranes at all times. Do not bandage.

    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 3-4 times daily. A temporary burning may be felt when applied, but usually disappears with continued use. Wash hands thoroughly after use to avoid spreading Lonol to the eyes or other sensitive areas of the body. If applying Lonol to the hands wait 30 minutes before washing hands. Initial pain relief is usually noted within 1-2 weeks. If condition does not improve in 4 weeks discontinue use of this product.
    Children under 12 years of age: consult doctor before use.

  • Other Information:

    Store at room temperature 20° to 25°C (68° to 77°F). To open press down on cap of bottle.

  • Inactive Ingredients:

    water, ethylhexyl palmitate, cetearyl alcohol, glycerin, propylene glycol, Arnica Extract, Aloe Barbadensis (Aloe Vera) Leaf Extract, Vitamin E Acetate, Carbomer, Aminomethyl propanol, Ethylhexylglycerin and Methylisothiazolinone

  • Packaging

    Lonlgel

  • INGREDIENTS AND APPEARANCE
    LONOL FORTE GEL 
    methyl salicylate, menthol, capsaicin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27854-255
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE20 g  in 100 mL
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 g  in 100 mL
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.002 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27854-255-011 in 1 CARTON01/28/2019
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/28/2019
    Labeler - Belmora LLC (112753244)