tritolnacide™ c

tritolnacide™ c
SPL v4
SPL
SPL Set ID 12b53c2a-b073-43db-88d9-ede8300626aa
Route
topical
Published
Effective Date 2024-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
tolnaftate (1 g)
Inactive Ingredients
alkyl (c12-15) benzoate butylparaben papaya safflower oil cetyl alcohol chamomile dimethicone, unspecified ethylparaben glycerin glyceryl monostearate hydrogenated polydecene type i isobutylparaben tea tree oil methylparaben peg-100 monostearate phenoxyethanol polyethylene glycol 400 propylene glycol propylparaben water sodium polyacrylate (2500000 mw) trideceth-6 xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-06-17

Purpose

Antifungal

Description

Drug Facts


Medication Information

Warnings

For external use only

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

Antifungal

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

Store at room temperature 20-28°C (68 - 82°F); do not store in extreme heat

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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

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)

Section 50568-5

Ask a physician or pharmacist before use if you are using any other medicines or cleansers on your skin

Section 50570-1

Do not use on children under 2 years of age unless directed by a physician

Active Ingredient

Tolnaftate 1%

Questions/comments?

(210) 944-6920

When Using This Product
  • Avoid contact with eyes: rinse immediately with cool tap water if contact occurs
  • Do not use for vaginal yeast
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)


Structured Label Content

Warnings

For external use only

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

Antifungal

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 (Other information)

Store at room temperature 20-28°C (68 - 82°F); do not store in extreme heat

Inactive Ingredients (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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

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)

Section 50568-5 (50568-5)

Ask a physician or pharmacist before use if you are using any other medicines or cleansers on your skin

Section 50570-1 (50570-1)

Do not use on children under 2 years of age unless directed by a physician

Active Ingredient (Active ingredient)

Tolnaftate 1%

Questions/comments? (Questions/Comments?)

(210) 944-6920

When Using This Product (When using this product)
  • Avoid contact with eyes: rinse immediately with cool tap water if contact occurs
  • Do not use for vaginal yeast
Principal Display Panel 37 Ml Pouch Tube Label (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)


Advanced Ingredient Data


Raw Label Data

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