FDA Label for Flanax
View Indications, Usage & Precautions
Flanax Product Label
The following document was submitted to the FDA by the labeler of this product Belmora Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active Ingredients
Methyl Salicylate 28%
Menthol 10%
Capsaicin 0.003%
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.
Otc - Keep Out Of Reach Of Children
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:
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
Packaging
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