Flanax Liniment by Belmora Llc FLANAX® LINIMENT

Flanax Liniment by

Drug Labeling and Warnings

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

Drug Details [pdf]

FLANAX LINIMENT- methyl salicylate, menthol, capsaicin liniment 
Belmora Llc

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.

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FLANAX® LINIMENT

Drug Facts

Active Ingredients

Methyl Salicylate 28%

Menthol 10%

Capsaicin 0.025%

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: Water, Aloe Barbadensis Leaf Juice, Isopropyl Palmitate, Glyceryl Stearate, Peg-100 Stearate, Cetearyl Alcohol

and Polysorbate 60, Propylene Glycol, Stearyl Alcohol, Phenoxyethanol, Benzoic Acid, Ethylhexylglycerin, Glycereth-2 Cocoate, Hydroxypropyl

Methyl Cellulose, Acrylates/C10-30alkyl Acrylate Crosspolymer, Salix Alba (Willow) Bark Extract, Zingiber Officinale (Ginger) Root Extract, 

Gaultheria Procumbens (Wintergreen) Leaf Extract, Zanthoxylum Americanum Bark Extract, Pinus Pinaster Bark/Bud Extract, Boswellia

Serrata Gum

Triple Action Pain Relief

Analgesic, Anesthetic and Anti-inflammatory Muscular Liniment

TORCEDURAS / SIMPLE BACK PAIN  ARTHRITIS  BRUISES  SPRAINS  STRAINS

WWW.FLANAXUSA.COM

Questions/Comments?

Distributed by Belmora LLC

2011 Crystal Dr. Suite 400

Arlington, VA 22202

1-888-799-2877 www.flanaxusa.com

Packaging

FLANAX LINIMENT 
methyl salicylate, menthol, capsaicin liniment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27854-400
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	0.025 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SALIX ALBA BARK (UNII: 205MXS71H7)
GINGER (UNII: C5529G5JPQ)
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)
ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T)
MARITIME PINE (UNII: 50JZ5Z98QY)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27854-400-01	1 in 1 CARTON	09/11/2020
1		30 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 not final	part348	09/11/2020

Labeler - Belmora Llc (112753244)

Revised: 9/2020

Document Id: 954a3d27-8e72-47ac-9f07-055a493635af

34390-5

Set id: e159d8ae-57c5-4a7a-ba1a-780436b46360

Version: 1

Effective Time: 20200914