Flanax Liniment

Manufacturer
Belmora Llc
Effective date
2020-09-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:15:03

Label at a glance#

ProductFlanax Liniment
Active ingredientMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, CAPSAICIN
Label structure9 sections

Storage and handling

Other Information: Store at room temperature 20° to 25°C (68° to 77°F).

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 28%

Menthol 10%

Capsaicin 0.025%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

INDICATIONS & USAGE SECTION

Uses: For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains, strains and

bruises

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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. 

STORAGE AND HANDLING SECTION

Other Information: Store at room temperature 20° to 25°C (68° to 77°F).

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackagingPackagingPackaging

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
27854-400-012024-01-30C16284748780-11030e365-6f07-111a-e063-dadaa90a10e2FLANAX ® LINIMENT

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
27854-40027854-400-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
954a3d27-8e72-47ac-9f07-055a493635afe159d8ae-57c5-4a7a-ba1a-780436b463602020-09-14WarningsExact identifier
spl id: 954a3d27-8e72-47ac-9f07-055a493635af
spl set id: e159d8ae-57c5-4a7a-ba1a-780436b46360

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.