Flanax Liniment Unit Dose Display by Belmora LLC FLANAX LINIMENT

Flanax Liniment Unit Dose Display by

Drug Labeling and Warnings

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

Drug Details [pdf]

FLANAX LINIMENT UNIT DOSE DISPLAY- 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.

Refer to display box for complete product information.

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. Thoroughly wash hands after application.

Inactive Ingredients:

Water, Aloe Barbadensis Leaf Juice, Isopropyl Palmitate, Glyceryl Stearate (and) Peg-100 Stearate, Cetearyl Alcohol and Polysorbate 60, Propylene Glycol, Stearyl Alcohol, Phenoxyethanol, Benzoic Acid, Ethylhexylglycerin, Glycereth-2 Cocoate, Hydroxypropyl Methyl Cellulose, Acrylates/C10-30 alkyl 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

Questions/Comments?

1888 779 2877

Belmora LLC, 3033 Wilson Blvd. Suite 700, Arlington, VA 22201

Packaging

FLANAX LINIMENT UNIT DOSE DISPLAY 
methyl salicylate, menthol, capsaicin liniment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27854-404
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: 27854-404-04	4 g in 1 TUBE; Type 0: Not a Combination Product	02/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/15/2022

Labeler - Belmora LLC (112753244)

Revised: 2/2022

Document Id: eb98339b-6b89-4082-9609-38f08e214cd9

34390-5

Set id: d8b51fa7-8511-42f5-b715-bd2ac0afcba5

Version: 1

Effective Time: 20220222