Tritolnacide™ S

Tritolnacide™ S
SPL v4
SPL
SPL Set ID b69ba7c9-03c1-4f5e-aa93-3ea1f2db15d8
Route
TOPICAL
Published
Effective Date 2023-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (0.01 g)
Inactive Ingredients
Mineral Oil Safflower Oil Jojoba Oil Butylated Hydroxytoluene Butylated Hydroxyanisole Oregano Leaf Oil .alpha.-tocopherol Phenoxyethanol Methylparaben Ethylparaben Isobutylparaben Butylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-11

Description

DRUG FACTS

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

DRUG FACTS

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.
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.

  • Do not use on children under 2 years of age unless directed by a doctor.
Warnings

For external use only.

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
Active Ingredient

Tolnaftate 1%

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.

Questions Or Comments?

CALL (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
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)
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)

Ask A Doctor Or Pharmacist Before Use If You Are
  • Using any other medicines or cleansers on your skin

Structured Label Content

Uses (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.
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.

  • Do not use on children under 2 years of age unless directed by a doctor.
Purpose (PURPOSE)

Antifungal

Warnings (WARNINGS)

For external use only.

Directions (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
Active Ingredient (ACTIVE INGREDIENT)

Tolnaftate 1%

Inactive Ingredients (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.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

CALL (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
Stop Use and Ask A Doctor If (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)
Principal Display Panel 15 Ml Bottle Label (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)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • Using any other medicines or cleansers on your skin

Advanced Ingredient Data


Raw Label Data

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