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| Product NDC Code | 73352-560 | ||||
|---|---|---|---|---|---|
| Drug Name | Tritolnacide s |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 313423, 2679333 |
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| Application Number | M005 | ||||
| Labeler Name | Trifluent Pharma 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 the affected area with soap and water 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 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 Supervise children in the use of this product 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 Wash hands after each use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Butylparaben, butylated hydroxyanisole, butylated hydroxytoluene, Carthamus tinctorius (safflower) seed oil, ethylparaben, isobutylparaben, methylparaben, Origanum vulgare (oregano) leaf oil, phenoxyethanol, propylparaben, Simmondsia chinensis (jojoba) seed oil, tocopherol, white mineral oil.
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 Treats most Athlete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris), and Ringworm (Tinea Corporis) Relieves discomfort, irritation, cracking, scaly skin between the toes and itching, burning feet.
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.Tritolnacide S Tolnaftate TOLNAFTATE TOLNAFTATE MINERAL OIL SAFFLOWER OIL JOJOBA OIL BUTYLATED HYDROXYTOLUENE BUTYLATED HYDROXYANISOLE OREGANO LEAF OIL .ALPHA.-TOCOPHEROL PHENOXYETHANOL METHYLPARABEN ETHYLPARABEN ISOBUTYLPARABEN BUTYLPARABEN PROPYLPARABEN
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 - 15 mL Bottle Label PRODUCT SHOULD BE ADMINISTERED UNDER THE SUPERVISION OF A LICENSED MEDICAL PRACTITIONER TRIFLUENT PHARMA ® TriTolnacide™ S ANTIFUNGAL SOLUTION TOLNAFTATE NDC 73352-560-01 0.5FL OZ (15 mL) PRINCIPAL DISPLAY PANEL - 15 mL Bottle 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.DRUG FACTS
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are Using any other medicines or cleansers on your skin
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 (1-800-222-1222) right away. Do not use on children under 2 years of age unless directed by a doctor.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS OR COMMENTS? CALL (210) 944-6920
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 or if there is no improvement within 4 weeks (for Athlete's Foot or Ringworm) or within 2 weeks (for Jock Itch)
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 eyes: rinse immediately with cool tap water if contact occurs. Do not use for vaginal yeast
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. Ask a doctor or pharmacist before use if you are Using any other medicines or cleansers on your skin When using this product Avoid contact with eyes: rinse immediately with cool tap water if contact occurs. Do not use for vaginal yeast Stop use and ask a doctor if Irritation occurs or if there is no improvement within 4 weeks (for Athlete's Foot or Ringworm) or within 2 weeks (for Jock Itch) Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Do not use on children under 2 years of age unless directed by a doctor.
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