TM -Tolnaftate by Singular Dreamer, Ltd dba True Marker

TM -Tolnaftate by

Drug Labeling and Warnings

TM -Tolnaftate by is a Otc medication manufactured, distributed, or labeled by Singular Dreamer, Ltd dba True Marker. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TM -TOLNAFTATE- tolnaftate 1% liquid 
Singular Dreamer, Ltd dba True Marker

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Active ingredients

Tolnaftate 1%

Purpose

Topical 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, if irritation occurs of if there is no improvement within 4 weeks, discontinue use and consult a doctor (within 2 weeks for jock itch)
• Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
• If pregnant or breast-feeding, ask a health professional before use.

Directions

• clean the affected area and dry thoroughly
• apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
• 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: 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
• This product is not effective on the scalp or nails.

Other information

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

Helianthus Annuus (Sunflower) Oil, Vitis Vinifera (Grape) Seed Oil, Mentha Piperita (Peppermint) Oil, Tocopheryl Acetate (Vitamin E), BHT (Butylated hydroxytoluene)

Questions?

304-742-2433

Product label

TM -TOLNAFTATE 
tolnaftate 1% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83035-1260
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: 83035-1260-3	1 in 1 CARTON	03/28/2023	11/01/2024
1		30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2	NDC: 83035-1260-4	45 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	08/10/2023	11/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	03/28/2023	11/01/2024

Labeler - Singular Dreamer, Ltd dba True Marker (129504103)

Registrant - Singular Dreamer, Ltd dba True Marker (129504103)

Revised: 10/2024

Document Id: 2516fb44-38b8-8bd3-e063-6394a90a5593

34390-5

Set id: 964ff52d-fd2a-47b4-bdc5-6a3ef2fc40bc

Version: 6

Effective Time: 20241022