FLANAX- capsaicin, menthol, methyl salicylate liniment

Flanax by

Drug Labeling and Warnings

Flanax by is a Otc medication manufactured, distributed, or labeled by Belmora LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Capsaicin 0.025%

Menthol 10%

Methyl Salicylate 23%

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

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 liniment to the eyes or other sensitive areas of the body. If applying liniment 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

Castor Oil, Cetearyl Alcohol 30/70 NF , Cetyl Esters NF, Ceteareth 20, Glyceryl Stearate, Propylene Glycol, Propyl paraben, Purified Water.

Questions/Comments

Distributed by Belmora LLC
PO Box 3063, Arlington, VA 22203
1-888-535-2629 www.flanaxusa.com

Packaging

INGREDIENTS AND APPEARANCE

FLANAX 
capsaicin, menthol, methyl salicylate liniment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27854-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.025 g  in 100 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	23 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ESTERS WAX (UNII: D072FFP9GU)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CASTOR OIL (UNII: D5340Y2I9G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27854-205-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/27/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/27/2016

Labeler - Belmora LLC (112753244)