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Tritolnacide c - Medication Information

Product NDC Code 73352-561
Drug Name

Tritolnacide c

Type Brand
Active Ingredients
Tolnaftate 1 g/100ml
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 103951,
2685262
Application Number M005
Labeler Name Trifluent Pharma LLC
Packages
Package NDC Code Description
73352-561-10 1 bottle, with applicator in 1 pouch (73352-561-10) / 37 ml in 1 bottle, with applicator
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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 affected area twice daily (morning and night) or as directed by a physician 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. For Jock Itch, use daily for 2 weeks. If condition persists longer, consult a physician This product is not effective on the scalp or nails To prevent Athlete's Foot, wash the feet and dry thoroughly; apply a thin layer of the product to the feet once or twice daily (morning and/or night) Wash hands after each use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Alkyl (C12-15) Benzoate, Butylparaben, Carica Papaya (Papaya) Fruit Extract, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, Emulsifying Wax, Ethylparaben, Glycerin, Glycerol Stearate, Hydrogenated Polydecene, Isobutylparaben, Melaleuca Alternifolia (Tea Tree) Oil, Methylparaben, PEG 100 Stearate, Phenoxyethanol, Polyethylene Glycol 400, Propylene Glycol, Propylparaben, Purfied Water, Sodium Polyacrylate, Trideceth-6, Xanthan Gum

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 itching, cracking, burning, and scaling, which accompany these conditions Clinically proven to prevent most Athlete's Foot (Tinea Pedis) with daily use Clears up most Athlete's Foot (Tinea Pedis) 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.
TriTolnacide C tolnaftate TOLNAFTATE TOLNAFTATE ALKYL (C12-15) BENZOATE BUTYLPARABEN PAPAYA SAFFLOWER OIL CETYL ALCOHOL CHAMOMILE DIMETHICONE ETHYLPARABEN GLYCERIN GLYCERYL MONOSTEARATE HYDROGENATED POLYDECENE TYPE I ISOBUTYLPARABEN TEA TREE OIL METHYLPARABEN PEG-100 STEARATE PHENOXYETHANOL POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM POLYACRYLATE (2500000 MW) TRIDECETH-6 XANTHAN GUM

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 - 37 mL Pouch Tube Label Tear at notch to open. Do not use if seal is broken. PRODUCT SHOULD BE ADMINISTERED UNDER THE SUPERVISION OF A LICENSED MEDICAL PRACTITIONER TRIFLUENT PHARMA™ TriTolnacide™ C TOLNAFTATE ANTIFUNGAL CREAM NDC 73352-561-10 1.25 FL. OZ. (37 mL) PRINCIPAL DISPLAY PANEL - 37 mL Pouch Tube 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 physician or pharmacist before use if you are using any other medicines or cleansers on your skin

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 physician

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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions/Comments? (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 physician 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

Storage and handling

Information about safe storage and handling of the drug product.
Other information Store at room temperature 20-28°C (68 - 82°F); do not store in extreme heat

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 physician Ask a physician 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 physician 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.

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