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| Product NDC Code | 27854-499 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Flanax |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LINIMENT | ||||||
| Application Number | M017 | ||||||
| Labeler Name | Belmora LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Methyl Salicylate 28% Menthol 10% Capsaicin 0.003%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses: For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains, strains, and bruises.
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.FLANAX Methyl Salicylate, Menthol, Capsaicin METHYL SALICYLATE SALICYLIC ACID MENTHOL, UNSPECIFIED FORM MENTHOL CAPSAICIN CAPSAICIN 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
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Packaging Flanax-499
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.Other Information: Store at room temperature 20° to 25°C (68° to 77°F).
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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. Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API