TOLNAFI-AL- tolnaftate liquid

Tolnafi-AL by

Drug Labeling and Warnings

Tolnafi-AL by is a Otc medication manufactured, distributed, or labeled by True Marker Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (s)

Tolnaftate 1%

Purpose

Antifungal

Uses

Proven clinically effective in the treatment of most fungal infections including related/associated to tinea pedis (athlete’s foot), tinea cruris (jock itch) and tinea corporis (ringworm)
For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort associated to fungal infections
Prevents most tinea pedis (athlete’s foot) with daily use.

Warnings

For external use only
Do Not Use– On children under 2 years of age unless directed by a doctor.
When using this product, avoid contact with eyes.
Stop use and ask a doctor 

• for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks
• for prevention of athlete's foot - if irritation occurs, discontinue use and consult a doctor 
• for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks 
• for prevention of athlete's foot - if irritation occurs, discontinue use and consult a doctor

Inactive ingredients

If swallwed, get medical help or contact a Poison Control Center right away

Directions

• clean the affected area and dry thoroughly 
• apply a thin layer of the product over affected area twice daily (morning and night) paying special attention to the edges of the nail, cuticles  and skin around the nails or as directed by a doctor 
• 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 
• if condition persists longer, consult a doctor.

Other information

• Store at 15 - 30°C (59 - 86°F) 
• avoid excessive heat 
• do not use if package is damaged

Inactive Ingredients

Helianthus annuus flowering top, Vitis Vinifera Fruit Oil, Peppermint, Alpha-Tocopherol Acetate, Butylated Hydroxytoluene.

Product label

INGREDIENTS AND APPEARANCE

TOLNAFI-AL 
tolnaftate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83592-480
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
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
VITIS VINIFERA FRUIT OIL (UNII: YQ5Q4Y2Z8U)
PEPPERMINT (UNII: V95R5KMY2B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83592-480-30	1 in 1 CARTON	08/01/2023
1		30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2	NDC: 83592-480-01	2 in 1 CARTON	08/01/2023
2		30 mL in 1 BOTTLE, GLASS; 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	08/01/2023

Labeler - True Marker Pharmaceuticals, Inc. (119046582)