Label: TOLNAFI-AL- tolnaftate liquid
- NDC Code(s): 83592-480-01, 83592-480-30
- Packager: True Marker Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 7, 2023
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- Official Label (Printer Friendly)
- Active Ingredient (s)
- Purpose
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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
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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
- Inactive Ingredients
- Product label
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INGREDIENTS AND APPEARANCE
TOLNAFI-AL
tolnaftate liquidProduct 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)
