FLANAX- methyl salicylate, menthol, capsaicin 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

Methyl Salicylate 28%
Menthol 10%
Capsaicin 0.003%

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 result 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 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).

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Boswellia Serrata Gum Extract, Cetearyl Alcohol, Ethyl Alcohol, Ethylhexylglycerin, Gaultheria Procumbens (Wintergreen) Leaf Extract, Glycerin, Glyceryl Stearate, Isopropyl Palmitate, PEG-100 Stearate, Phenoxyethanol, Polysorbate 60, Propylene Glycol, Salix Alba (Willow) Bark Extract, Stearyl Alcohol, Triethanolamine, Water

SPL UNCLASSIFIED SECTION

Analgesic, Anesthetic and Anti-inflammatory Muscular Liniment

Triple Action Pain Relief

Questions/Comments:
Distributed by Belmora LLC
3033 Wilson Blvd. Suite 700
Arlington, VA 22201
1-888-779-2877

WWW.FLANAXUSA.COM

Packaging

INGREDIENTS AND APPEARANCE

FLANAX 
methyl salicylate, menthol, capsaicin liniment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27854-499
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	28 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.003 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S AT 0.5%) (UNII: YY2HMJ9NZF)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALCOHOL (UNII: 3K9958V90M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PEG-100 MONOSTEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SALIX ALBA BARK (UNII: 205MXS71H7)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27854-499-01	1 in 1 CARTON	08/01/2024
1		28.35 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	08/01/2024

Labeler - Belmora LLC (112753244)