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| Product NDC Code | 49406-003 | ||||
|---|---|---|---|---|---|
| Drug Name | Formula 3 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 313423 | ||||
| Application Number | M005 | ||||
| Labeler Name | The Tetra Corporation | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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 For treatment of athlete's foot and ringworm 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. 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. For athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor. This product is not effective on scalp or nail. To prevent athlete's foot: Clean the feet and dry thoroughly. Apply a thin layer of the product to the feet once or twice daily (morning and/or night) Supervise children in the use of this product. Pay special attention to spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Apricot Kernel Oil, Rice Bran Oil, Sesame Seed Oil, Safflower Oil, Jojoba Oil, Vitamin E Acetate, Methyl Paraben, Propyl Paraben and Butyl Paraben.
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 and ringworm. Relieves: Itching Soreness Scaling Burning Cracking Irritation Redness Prevents the recurrence of most athlete's foot (dermatophytosis) with daily use.
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.Formula 3 TOLNAFTATE APRICOT KERNEL OIL RICE BRAN OIL SESAME OIL SAFFLOWER OIL JOJOBA OIL .ALPHA.-TOCOPHEROL ACETATE METHYLPARABEN PROPYLPARABEN BUTYLPARABEN 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.FORMULA 3 BRAND Antifungal Tolnaftate 1% Antifungal Solution 15ml (49406-003-15) Representative Labeling outer label outer inner label inner label
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.FORMULA 3
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.
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 eyes. Stop use and ask a doctor if When using for athlete's foot or ringworm: If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor. When using for the prevention of athlete's foot: If irritation occurs,discontinue use and consult a doctor. If pregnant or breastfeeding ask a health professional before use.
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