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| Product NDC Code | 36800-049 | ||||
|---|---|---|---|---|---|
| Drug Name | Athletes foot |
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| Type | Brand | ||||
| Pharm Class | Benzylamine Antifungal [EPC], Benzylamines [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1298448 | ||||
| Application Number | ANDA205181 | ||||
| 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 Butenafine hydrochloride 1%
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 and older: use the tip of the cap to break the seal and open the tube wash the affected skin with soap and water and dry completely before applying for athlete's foot between the toes: apply to affected skin between and around the toes twice a day for 1 week (morning and night), or once a day for 4 weeks, or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. Apply between and around the toes 1 week twice a day or 4 weeks once a day for jock itch and ringworm: apply once a day to affected skin for 2 weeks or as directed by a doctor. wash hands after each use children under 12 years: ask a doctor figure
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzyl alcohol, cetyl alcohol, glycerin, glyceryl monostearate SE, polyoxyethylene (23) cetyl ether, propylene glycol dicaprylate, purified water, sodium benzoate, stearic acid, trolamine, white petrolatum
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 cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown. cures most jock itch and ringworm relieves itching, burning, cracking, and scaling which accompany these conditions
Purpose
Information about the drug product’s indications for use.Purpose Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.Athletes Foot Butenafine Hydrochloride Butenafine Hydrochloride Butenafine benzyl alcohol cetyl alcohol glycerin Glyceryl Stearate Se CETETH-23 propylene glycol dicaprylate water sodium benzoate stearic acid trolamine petrolatum
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 - 12 g Tube Carton TopCare ® health ™ PRESCRIPTION STRENGTH Athlete's Foot Cream Ultra BUTENAFINE HYDROCHLORIDE CREAM 1% • ANTIFUNGAL NET WT 0.42 OZ (12 g) OUR PHARMACISTS • RECOMMEND • Principal Display Panel - 12 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 TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007
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 nails or scalp in or near the mouth or the eyes for vaginal yeast infections
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? 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 ask a doctor if too much irritation occurs or irritation gets worse
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 the eyes. If eye contact occurs, rinse thoroughly with water.
Storage and handling
Information about safe storage and handling of the drug product.Other information do not use if seal on tube is broken or not visible store between 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 on nails or scalp in or near the mouth or the eyes for vaginal yeast infections When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if too much irritation occurs or irritation gets worse 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