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| Product NDC Code | 36800-023 | ||||
|---|---|---|---|---|---|
| Drug Name | Tolnaftate |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | AEROSOL, SPRAY | ||||
| RxCUI drug identifier | 705934 | ||||
| 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 Tolnaftate 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 wash affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) supervise children in the use of this product for athlete's foot: pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily use daily for 4 weeks if conditions persist, consult a doctor to prevent athlete's foot, apply once or twice daily (morning and/or night) in case of clogging, clear nozzle under running water
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients disteardimonium hectorite, fragrance, isobutane, isopropyl myristate, SD alcohol 40-B, sodium bicarbonate
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 prevents recurrence of athlete's foot (tinea pedis) with daily use cures mose athlete's foot (tinea pedis) and ringworm (tinea corporis) relieves sypmtoms of athlete's foot, including itching, burning and cracking
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.Tolnaftate Foot Odor Control Spray DISTEARDIMONIUM HECTORITE ISOBUTANE ISOPROPYL MYRISTATE ALCOHOL SODIUM BICARBONATE TOLNAFTATE TOLNAFTATE
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 TopCare MEDICATED Foot Odor Control Powder Spray TOLNAFTATE % • ANTIFUNGAL Cures Most Athlete's Foot & Prevents Recurrences Reduces Foot Odor Relieves Itching, Burning & Cracking NET WT 4 OZ (113g) Foot Odor Control Spray
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 under 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 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 between 20º and 30ºC (68ºF and 86º)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? call 1-866-964-0939
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 irritation occurs no improvement within 4 weeks
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 the eyes or mouth
Safe handling warning
Safe Handling WarningFlammable: Keep away from heat, sparks and open flame. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120ºF. Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.
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. Flammable: Keep away from heat, sparks and open flame. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120ºF. Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal. When using this product avoid contact with the eyes or mouth Stop use and ask a doctor if irritation occurs no improvement within 4 weeks Do not use on children under 2 years of age unless directed by a doctor 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