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| Product NDC Code | 71335-2249 | ||||
|---|---|---|---|---|---|
| Drug Name | Tolnaftate antifungal |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | POWDER | ||||
| RxCUI drug identifier | 313422 | ||||
| Application Number | M005 | ||||
| Labeler Name | Bryant Ranch Prepack | ||||
| 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 • shake well before use • clean the affected area and dry thoroughly • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor • supervise children in the use of this product • use daily for 4 weeks. If condition persists longer, consult a doctor. 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 • to prevent athlete’s foot, clean and dry feet thoroughly. Apply as above once or twice daily. 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 corn starch and talc
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 effective treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis) • for effective relief of itchy, scaly skin between the toes • clears up most athlete’s foot infection and with daily use helps keep it from coming back
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 ANTIFUNGAL TOLNAFTATE STARCH, CORN TALC 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.Tolnaftate 1% Powder #45 Label
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 room temperature
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED NDC: 71335-2249-1: 45 g in a BOTTLE
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 under 2 years of age unless directed by a doctor. When using this product avoid contact with the eyes Stop use and consult a doctor if • irritation occurs • there is no improvement within 4 weeks
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