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| Product NDC Code | 43251-2400 | ||||
|---|---|---|---|---|---|
| Drug Name | Flexitol foot and knee pain relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 2603664 | ||||
| Application Number | part348 | ||||
| Labeler Name | LaCorium Health USA Inc. | ||||
| 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 ingredient Methyl Salicylate10%
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 2 years of age and older: apply to affected area not more than 3 - 4 times daily Children under 2 years of age: consult a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients arnica montana flower extract, benzyl alcohol, C13-14 isoparaffin, ethanol, laureth-7, PEG-40 hydrogenated castor oil, peppermint oil, polyacrylamide, tocopherol, 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: strains bruises sprains arthritis
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.Flexitol Foot and Knee Pain Relief Methyl Salicylate Methyl Salicylate SALICYLIC ACID POLYOXYL 40 HYDROGENATED CASTOR OIL Alcohol C13-14 Isoparaffin Laureth-7 Arnica Montana Flower Peppermint oil Benzyl alcohol Tocopherol POLYACRYLAMIDE (1300000 MW)
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.PRINCIPAL DISPLAY PANEL - 56 g Tube Carton NDC: 43251-2400-1 Flexitol ® FOOT & KNEE PAIN RELIEF GEL PAIN RELIEF FOR FOOT & KNEE PAIN ASSOCIATED WITH: STRAINS BRUISES SPRAINS ARTHRITIS NON-GREASY, QUICK ABSORBING WITH METHYL SALICYLATE 10% TOPICAL ANALGESIC AUSTRALIAN MADE & OWNED Net Wt. 2 oz (56 g) GEL PRINCIPAL DISPLAY PANEL - 56 g Tube Carton
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
DISTRIBUTED BY: LaCorium Health USA Inc 801 Broad St, Suite 600 Chattanooga, TN 37402
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on broken skin
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? Call Toll Free 1-866-478-3338 [email protected] www.flexitol.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not get into eyes if contact occurs, rinse eyes thoroughly with water do not use on broken skin do not bandage tightly do not use other than as directed
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store between 50-86˚F in a dry place Do not use if tube seal is broken or appears tampered with
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 Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days When using this product do not get into eyes if contact occurs, rinse eyes thoroughly with water do not use on broken skin do not bandage tightly do not use other than as directed Do not use on broken skin 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