TRITOLNACIDE S- tolnaftate solution

Tritolnacide S by

Drug Labeling and Warnings

Tritolnacide S by is a Otc medication manufactured, distributed, or labeled by Trifluent Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

Tolnaftate 1%

PURPOSE

Antifungal

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.

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.

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 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

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)

INGREDIENTS AND APPEARANCE

TRITOLNACIDE S 
tolnaftate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73352-560
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	0.01 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
SAFFLOWER OIL (UNII: 65UEH262IS)
JOJOBA OIL (UNII: 724GKU717M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73352-560-01	15 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	12/11/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M005	12/11/2023

Labeler - Trifluent Pharma LLC (117167281)