derman antifungal

derman antifungal
SPL v24
SPL
SPL Set ID 0129d801-90f6-49fd-857f-27d6ba9fc66c
Route
topical
Published
Effective Date 2019-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
undecylenic acid (5 g)
Inactive Ingredients
glycerin polyethylene glycol 500 polyethylene glycol 4000 propylene glycol cetyl alcohol sodium bisulfite sodium laureth sulfate water zinc stearate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2013-08-12
Purpose

Antifungal

Description

Zinc undecylenate  18% Undecylenic acid    5%

Medication Information

Warnings

For external use only

Uses

For the treatment of athlete´s foot.

Purpose

Antifungal

Directions
  • Wash the affected area and dry thoroughly. 
  • Apply a thin layer of the product over the 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. 
  • Use daily for 4 weeks. 
  • If condition persists, consults a physician. 
  • This product is not effective on the scalp or nails.
Inactive Ingredients

Cetyl alcohol, Glycerin, Polyethylene Glycol 500, Polyethylene glycol 4000, Propylene glycol, Sodium bisulfite, Sodium laureth sulfate, water, Zinc stearate.

Description

Zinc undecylenate  18% Undecylenic acid    5%

Section 42229-5

Do Not Use

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

Active Ingredients.

Zinc undecylenate  18%

Undecylenic acid    5%

Stop Use and Ask A Doctor

if irritation occurs or if there is no improvement within 4 weeks.

When Using This Product 

Avoid contact with the eyes.

Derman Antifungal (54312 125 01)

Derman Antifungal (54312 125 02)

Keep Out of the Reach of Children.

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

Structured Label Content

Warnings

For external use only

Uses

For the treatment of athlete´s foot.

Purpose

Antifungal

Directions
  • Wash the affected area and dry thoroughly. 
  • Apply a thin layer of the product over the 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. 
  • Use daily for 4 weeks. 
  • If condition persists, consults a physician. 
  • This product is not effective on the scalp or nails.
Inactive Ingredients (Inactive ingredients)

Cetyl alcohol, Glycerin, Polyethylene Glycol 500, Polyethylene glycol 4000, Propylene glycol, Sodium bisulfite, Sodium laureth sulfate, water, Zinc stearate.

Section 42229-5 (42229-5)

Do Not Use (Do not use)

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

Active Ingredients.

Zinc undecylenate  18%

Undecylenic acid    5%

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if irritation occurs or if there is no improvement within 4 weeks.

When Using This Product  (When using this product )

Avoid contact with the eyes.

Derman Antifungal (54312 125 01) (Derman Antifungal (54312-125-01))

Derman Antifungal (54312 125 02) (Derman Antifungal (54312-125-02))

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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:16.966057 · Updated: 2026-03-14T23:10:32.676275