Comfort Zone Maximum Strength Antifungal Liquid

Comfort Zone Maximum Strength Antifungal Liquid
SPL v3
SPL
SPL Set ID 24b22794-f9f8-6f32-e063-6394a90aec98
Route
TOPICAL
Published
Effective Date 2024-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Water Xanthan Gum Ethylhexylglycerin Glycerin Edetate Disodium Phenoxyethanol Betasizofiran

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-10-17 Until 2026-11-30

Description

Tolnaftate 1% w/w

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Tolnaftate 1% w/w

Uses
  • proven clinically effective in the treament of most athlete's foot (tinea pedis) and ring worm (tinea corporis).
  • prevents the recurrence of most athlete's foot with daily use
  • for effective relief of itching, burning, cracking, redness and scaling,
Warnings

For external use only.

Do Not Use

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

Questions?

Call 1-877-237-0194

​purpose

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 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.
  • to prevent athlete's foot: wash the feet and dry thoroughly; apply a thin layer of the product to the feet once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails.
​active Ingredient

Tolnaftate 1% w/w

​other Information
  • SHAKE WELL BEFORE USE
  • store at room temperature 15°-30°C (59° - 86°F)
  • protect from freezing; if freezing occurs, warm to room temperature
  • keep tightly closed when not in use.
​inactive Ingredient

WATER, GLYCERIN, SCLEROTIUM GUM, PHENOXYETHANOL, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, XANTHAN GUM

Principal Display Panel

comfort zone

maximum strength

antifungal liquid

tolnaftate 1%/antifungal

Prevents the recurrence

of most athlete's foot

with daily use

Proven clinically effective

in the treatment of fungus

on fingers, toes and skin

around nails

relieves itching, burning & scaling

with moisturizing ingredients

built-in applicator brush

SHAKE WELL BEFORE USE

1 FL. OZ.

(30 mL)

When Using This Product

avoid contact with the eyes.

Keep Out of Reach of Children.

If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.

Stop Use and Consult A Doctor If
  • irritation occurs
  • there is no improvement within 4 weeks.

Structured Label Content

Uses
  • proven clinically effective in the treament of most athlete's foot (tinea pedis) and ring worm (tinea corporis).
  • prevents the recurrence of most athlete's foot with daily use
  • for effective relief of itching, burning, cracking, redness and scaling,
Warnings

For external use only.

Do Not Use (Do not use)

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

Questions?

Call 1-877-237-0194

​purpose (​Purpose)

Antifungal

​directions (​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 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.
  • to prevent athlete's foot: wash the feet and dry thoroughly; apply a thin layer of the product to the feet once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails.
​active Ingredient (​Active ingredient)

Tolnaftate 1% w/w

​other Information (​Other information)
  • SHAKE WELL BEFORE USE
  • store at room temperature 15°-30°C (59° - 86°F)
  • protect from freezing; if freezing occurs, warm to room temperature
  • keep tightly closed when not in use.
​inactive Ingredient (​Inactive ingredient)

WATER, GLYCERIN, SCLEROTIUM GUM, PHENOXYETHANOL, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, XANTHAN GUM

Principal Display Panel

comfort zone

maximum strength

antifungal liquid

tolnaftate 1%/antifungal

Prevents the recurrence

of most athlete's foot

with daily use

Proven clinically effective

in the treatment of fungus

on fingers, toes and skin

around nails

relieves itching, burning & scaling

with moisturizing ingredients

built-in applicator brush

SHAKE WELL BEFORE USE

1 FL. OZ.

(30 mL)

When Using This Product (When using this product)

avoid contact with the eyes.

Keep Out of Reach of Children. (Keep out of reach of children.)

If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.

Stop Use and Consult A Doctor If (Stop use and consult a doctor if)
  • irritation occurs
  • there is no improvement within 4 weeks.

Advanced Ingredient Data


Raw Label Data

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