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| Product NDC Code | 55758-360 | ||||
|---|---|---|---|---|---|
| Drug Name | Flexsport roll on |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | part348 | ||||
| Labeler Name | Pharmadel 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 ingredient and Purpose Active ingredient Purpose Menthol 16% .................... Topical analgesic
| Menthol 16% .................... | Topical analgesic |
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 use only as directed adults and children over 12 years: apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer, alcohol, capsaicin, glycerin, isopropyl myristate, propylene glycol, trolamine, 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: arthritis simple backache muscle strains sprains bruises
Purpose
Information about the drug product’s indications for use.Active ingredient Purpose Menthol 16% .................... Topical analgesic
| Menthol 16% .................... | Topical analgesic |
Spl product data elements
Usually a list of ingredients in a drug product.FlexSport Roll On Methyl Salicylate POLYACRYLIC ACID (250000 MW) DMDM HYDANTOIN ARNICA MONTANA FLOWER METHYL SALICYLATE SALICYLIC ACID TROLAMINE EUCALYPTUS OIL CAPSAICIN PROPYLENE GLYCOL WATER ISOPROPYL ALCOHOL MENTHOL POLYSORBATE 20 ALPHA-TOCOPHEROL ACETATE CAMPHOR (SYNTHETIC)
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 Topical Analgesic Liquid FlexSport Pain Relief ROLL-ON Muscle & Joint Pain Backaches Arthritis 3 fl oz (89 mL) FS PDP
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
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store at temperatures not exceeding 15°–30°C (59°– 86°F) avoid excessive heat and humidity
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? 1-866-359-3478 (M-F) 9 AM – 5 PM EST or www.pharmadel.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 redness is present irritation develops symptoms persist for 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 bandage tightly or use with a heating pad do not apply to wounds or damaged, broken or irritated skin
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
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. Avoid contact with the eyes. Flammable: keep away from fire or flame. When using this product do not bandage tightly or use with a heating pad do not apply to wounds or damaged, broken or irritated skin Stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breast-feeding, ask a health professional before use. 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