Label: TM -TOLNAFTATE- tolnaftate 1% liquid
- NDC Code(s): 83035-1260-3, 83035-1260-4
- Packager: Singular Dreamer, Ltd dba True Marker
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 11, 2023
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- Official Label (Printer Friendly)
- Active ingredients
- 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.
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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.
- KEEP OUT OF REACH OF CHILDREN
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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) 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
- Inactive ingredients
- Questions?
- Product label
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INGREDIENTS AND APPEARANCE
TM -TOLNAFTATE
tolnaftate 1% liquidProduct 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 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 03/28/2023 Labeler - Singular Dreamer, Ltd dba True Marker (129504103) Registrant - Singular Dreamer, Ltd dba True Marker (129504103)