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| Product NDC Code | 36800-754 | ||||
|---|---|---|---|---|---|
| Drug Name | Topcare antifungal maximum strength |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | M005 | ||||
| Labeler Name | TOPCO ASSOCIATES LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Undecylenic Acid 25%
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 Read all warnings and directions. Use only as directed. ▪ clean the affected area with soap and warm water and dry thoroughly. ▪ Apply a thin layer of Anti-Fungal liquid solution over affected area twice daily (morning and night) or as directed by a doctor. ▪ The brush applicator allows for easy application under nails and surrounding cuticle area. ▪ wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. ▪ for athlete's foot: pay special attention to spaces between toes. ▪ For athlete's foot and ringworm, use daily for 4 weeks. If conditions persists longer, consult a doctor . ▪ this product is not effective on the scalp or nails. ▪ Supervise children in the use of this product.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient Isopropyl palmitate
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 ▪ Proven effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis) ▪ For effective relief of itching, burning and cracking.
Purpose
Information about the drug product’s indications for use.Purpose Anti-fungal
Spl product data elements
Usually a list of ingredients in a drug product.TopCare Antifungal Maximum Strength Undecylenic Acid UNDECYLENIC ACID UNDECYLENIC ACID ISOPROPYL PALMITATE
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 NDC 36800-754-01 COMPARE TO FUNGICURE® active ingredient* MAXIMUM STRENGTH Anti-Fungal Liquid • Topical formula for toe and foot • Stops most athlete’s foot fungus and ringworm • Helps relieves related discomforts 1 FL OZ (30mL) QUALITY GURANTEED This Top Care® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed. Side Panel How to Eliminate Fungus? Toe fungus can affect the areas around the cuticles and the skin around the tip of the nails. Anti-fungal work on contact but do not penetrate the nail, So make sure tom keep nails clipped and clean away flaky skin and nail keratin when treating affected areas. Anti-Fungal Liquid solution gets into hard to reach places, right where it’s needed, to treat fungus and stop it from spreading. When will you see results? • Anti-Fungal Liquid begins working immediately to eliminate toe and athlete’s foot fungus. • You should begin to see results in 4 weeks. • You may need to continue treating to allow for regrowth of healthy new tissue. *This product is not manufactured or distributed by Alva-Amco Pharmacal Companies, the distributor of FungiCure ® . DISTRIBUTED BY TOPCO ASSOCIATES LLC ELKGROVE VILLAGE, IL 60007 © TOPCO RSE515 QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com Anti- Fungal Liquid TopCare Maximum Strength 30 mL
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 children 2 years of age unless directed by a doctor.
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 THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN. If case of accidental ingestion, contact a physician, emergency medical care facility, or Poison Control Center immediately for advice at 1-800-222-1222.
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 room temperature 15°-30°C (59° - 86°F). • Protect from freezing. If freezing occurs warm to room temperature.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-888-423-0139
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 consult a doctor if ▪ there is no improvement within 4 weeks ▪ irritation occurs
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 ▪ avoid contact with eyes
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 on children 2 years of age unless directed by a doctor. When using this product ▪ avoid contact with eyes Stop use and consult a doctor if ▪ there is no improvement within 4 weeks ▪ irritation occurs KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN. If case of accidental ingestion, contact a physician, emergency medical care facility, or Poison Control Center immediately for advice at 1-800-222-1222.
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