drug facts

drug facts
SPL v1
SPL
SPL Set ID 21b643c2-eb6e-8939-e063-6394a90aaeac
Route
topical
Published
Effective Date 2024-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
tolnaftate (10 mg)
Inactive Ingredients
zinc oxide glycerin ethoxydiglycol dipropylene glycol caprylate ceteth-23 simmondsia chinensis (jojoba) seed oil water caprylic/capric triglyceride diethyl sebacate sorbitan stearate phenoxyethanol hexadecane polyacrylate crosspolymer-6 cetyl alcohol lactic acid dimethicone urea hydroxyethylcellulose squalane glycine sodium dilauramidoglutamide lysine tridecyl stearate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-09-12

Purpose

Tolnaftate - Antifungal

Description

Tolnaftate 1%


Medication Information

Warnings

For external use only

Uses
  • proven clinically effective in the treatment of most cracked heel athlete’s foot
  • relieves cracking, irritation and discomfort
  • prevents the recurrence of most cracked heel athlete's foot with daily use
  • Clears up most athlete’s foot infection and with daily use helps keep it from coming back
Purpose

Tolnaftate - Antifungal

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
  • supervise children in the use of this product
  • for athlete’s foot: pay special attention to the areas between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • for athlete's foot, use daily for 4 weeks. If condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails
Inactive Ingredients

water, caprylic/capric triglyceride, urea, cetyl alcohol, glycerin, glycine, hexadecane, tridecyl stearate, ethoxydiglycol, ceteth-23, polyacrylate crosspolymer-6, diethyl sebacate, dimethicone, hydroxyethylcellulose, lactic acid, phenoxyethanol, propylene glycol caprylate, simmondsia chinensis (jojoba) seed oil, sodium dilauramidoglutamide lysine, sorbitan stearate, squalane, zinc oxide

Description

Tolnaftate 1%

Questions?

1-877-636-2677 MON-FRI 9AM-5PM (EST)

Do Not Use

on children under 2 years of age unless directed by a doctor.

Drug Facts

Prinicipal Display Panel

Active Ingredient

Tolnaftate 1%

When Using This Product,

avoid contact with the eyes.

Stop Use and Ask A Doctor If
  • irritation occurs
  • there is no improvement within 4 weeks
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Central right away


Structured Label Content

Warnings

For external use only

Uses
  • proven clinically effective in the treatment of most cracked heel athlete’s foot
  • relieves cracking, irritation and discomfort
  • prevents the recurrence of most cracked heel athlete's foot with daily use
  • Clears up most athlete’s foot infection and with daily use helps keep it from coming back
Purpose

Tolnaftate - Antifungal

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
  • supervise children in the use of this product
  • for athlete’s foot: pay special attention to the areas between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • for athlete's foot, use daily for 4 weeks. If condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails
Inactive Ingredients (Inactive ingredients)

water, caprylic/capric triglyceride, urea, cetyl alcohol, glycerin, glycine, hexadecane, tridecyl stearate, ethoxydiglycol, ceteth-23, polyacrylate crosspolymer-6, diethyl sebacate, dimethicone, hydroxyethylcellulose, lactic acid, phenoxyethanol, propylene glycol caprylate, simmondsia chinensis (jojoba) seed oil, sodium dilauramidoglutamide lysine, sorbitan stearate, squalane, zinc oxide

Questions?

1-877-636-2677 MON-FRI 9AM-5PM (EST)

Do Not Use (Do not use)

on children under 2 years of age unless directed by a doctor.

Drug Facts

Prinicipal Display Panel

Active Ingredient (Active ingredient)

Tolnaftate 1%

When Using This Product, (When using this product,)

avoid contact with the eyes.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation occurs
  • there is no improvement within 4 weeks
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Central right away


Advanced Ingredient Data


Raw Label Data

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