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| Product NDC Code | 11527-051 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Tolnaftate |
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| Type | Generic | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| RxCUI drug identifier | 103951 | ||||||
| Application Number | M005 | ||||||
| Labeler Name | Sheffield Pharmaceuticals LLC | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Tolnaftate USP 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 Clean the affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. For athlete's foot Pay special attention to the spaces between the toes. Wear well fitting ventilated shoes. Change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, White Petrolatum, Propylene Glycol, Sodium Phosphate Monobasic, 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 Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis). Relieves the itching, irratation, redness, scaling and discomfort which can accompany these conditions.
Purpose
Information about the drug product’s indications for use.Purpose Antifungal Cream
Spl product data elements
Usually a list of ingredients in a drug product.Tolnaftate TOLNAFTATE TOLNAFTATE TOLNAFTATE WATER CETOSTEARYL ALCOHOL CETETH-20 CHLOROCRESOL MINERAL OIL PETROLATUM SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS PROPYLENE GLYCOL
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 – 1.25 oz Tube Dr. Sheffield's NDC 11527-051-40 Antifungal Cream (Tolnaftate 1%) Made in the USA CURES Most: ATHLETE'S FOOTJOCK ITCH RINGWORM Net Wt. 1.25 OZ (35.4 g) Principal Display Panel – 1.25 oz Tube
Principal Display Panel – 1.25 oz Carton Dr. Sheffield's NDC 11527-051-40 CURES Most: ATHLETE'S FOOTJOCK ITCH RINGWORM Net Wt. 1.25 OZ (35.4 g) Principal Display Panel – 1.25 oz 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
Other information Store at controlled room temperature 15°-30°C (59°-86°F). Close cap tighty after ever use.
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 drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-222-1087
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 Do not use on children under 2 years of age unless directed by a doctor. For external use only avoid contact with eyes. Irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)irritation occurs or if there is no improvement within 2 weeks (for jock itch).
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