Flanax®

Flanax®
SPL v1
SPL
SPL Set ID 5e06c688-a086-4c1c-8dab-fcead61fef40
Route
TOPICAL
Published
Effective Date 2024-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (28 g) Menthol (10 g) Capsaicin (0.003 g)
Inactive Ingredients
Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s At 0.5%) Aloe Vera Leaf Indian Frankincense Cetostearyl Alcohol Alcohol Ethylhexylglycerin Gaultheria Procumbens Leaf Glycerin Glyceryl Monostearate Isopropyl Palmitate Peg-100 Monostearate Phenoxyethanol Polysorbate 60 Propylene Glycol Salix Alba Bark Stearyl Alcohol Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-01

Description

Methyl Salicylate 28% Menthol 10% Capsaicin 0.003%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Methyl Salicylate 28% Menthol 10% Capsaicin 0.003%

Uses:

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

Section 42229-5

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

Section 50565-1

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

Packaging

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.  

Drug Facts

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. 

Active Ingredients

Methyl Salicylate 28%

Menthol 10%

Capsaicin 0.003%

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


Structured Label Content

Uses:

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

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

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

Purpose

Topical Analgesic

Packaging

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.  

Drug Facts

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. 

Active Ingredients

Methyl Salicylate 28%

Menthol 10%

Capsaicin 0.003%

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


Advanced Ingredient Data


Raw Label Data

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