Label: LONOL FORTE GEL- methyl salicylate, menthol, capsaicin gel
- NDC Code(s): 27854-255-01
- Packager: Belmora 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.
Updated June 28, 2019
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- Drug Facts
- Active Ingredients
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.
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:
- Inactive Ingredients:
INGREDIENTS AND APPEARANCE
LONOL FORTE GEL
methyl salicylate, menthol, capsaicin gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:27854-255 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 20 g in 100 mL MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 10 g in 100 mL CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.002 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:27854-255-01 1 in 1 CARTON 01/28/2019 1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/28/2019 Labeler - Belmora LLC (112753244)