Flanax

Manufacturer
Belmora LLC
Effective date
2019-10-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:07:48

Label at a glance#

ProductFlanax
Active ingredientCAPSAICIN, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure10 sections

Indications and uses

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

Dosage and administration

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 ...

Storage and handling

Store at room temperature 20° to 25°C (68° to 77°F). To open press down on cap of bottle.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.025%

Menthol 10%

Methyl Salicylate 23%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Store at room temperature 20° to 25°C (68° to 77°F). To open press down on cap of bottle.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions/Comments

OTC - QUESTIONS SECTION

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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
27854-20527854-205-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
fc5cf367-2661-4256-b938-dabf1c4f8259f7de204f-e5e8-4861-91ca-2c44d1d15fe92020-10-08WarningsExact identifier
spl set id: f7de204f-e5e8-4861-91ca-2c44d1d15fe9

Reported adverse events (FAERS/openFDA)#

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