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

Description

Tolnaftate 1%

Purpose

Tolnaftate - Antifungal


Medication Information

Purpose

Tolnaftate - Antifungal

Description

Tolnaftate 1%

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
Warnings

For external use only

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
Do Not Use

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

Drug Facts

Prinicipal Display Panel

Questions?

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

Active Ingredient

Tolnaftate 1%

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

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

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

Warnings

For external use only

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
Do Not Use (Do not use)

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

Drug Facts

Prinicipal Display Panel

Questions?

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

Active Ingredient (Active ingredient)

Tolnaftate 1%

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

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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