Label: TRITOLNACIDE C- tolnaftate cream
- NDC Code(s): 73352-561-10
- Packager: Trifluent Pharma LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 12, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
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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
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Warnings
For external use only
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
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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
- Other information
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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
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- PRINCIPAL DISPLAY PANEL - 37 mL Pouch Tube Label
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INGREDIENTS AND APPEARANCE
TRITOLNACIDE C
tolnaftate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73352-561 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 1 g in 100 mL Inactive Ingredients Ingredient Name Strength ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) BUTYLPARABEN (UNII: 3QPI1U3FV8) PAPAYA (UNII: KU94FIY6JB) SAFFLOWER OIL (UNII: 65UEH262IS) CETYL ALCOHOL (UNII: 936JST6JCN) CHAMOMILE (UNII: FGL3685T2X) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLPARABEN (UNII: 14255EXE39) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) TEA TREE OIL (UNII: VIF565UC2G) METHYLPARABEN (UNII: A2I8C7HI9T) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TRIDECETH-6 (UNII: 3T5PCR2H0C) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73352-561-10 1 in 1 POUCH 06/17/2024 1 37 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M005 06/17/2024 Labeler - Trifluent Pharma LLC (117167281)
