DERMAN ANTIFUNGAL- zinc undecylenate, undecylenic acid powder

DERMAN ANTIFUNGAL by

Drug Labeling and Warnings

DERMAN ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by Compania Internacional de Comercio, S.A.P.I. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Undecylenic acid 2%

Zinc undecylenate 20%

Purpose

Antifungal

Uses

For the treatment of athlete's foot
Relieves itching scaling cracking burning

Warnings

For external use only.

Do not use

on children under 12 years of age unless directed by a doctor.

When using this product

avoid contact with the eyes.

Stop use and ask a doctor

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

Keep out of reach of children.

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

Directions

• Wash 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.
• Use daily for 4 weeks.
• If condition persists longer, consult a doctor.
• This product is not effective on the scalp or nails.

Inactive ingredients

Fragrance, Koalin, Talc, Zinc Stearate

Package Labeling:

Derman Antifungal Powder, 80g (

54312-925-01)

INGREDIENTS AND APPEARANCE

DERMAN ANTIFUNGAL 
zinc undecylenate, undecylenic acid powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54312-925
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	2 g  in 100 g
ZINC UNDECYLENATE (UNII: 388VZ25DUR) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	ZINC UNDECYLENATE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
KAOLIN (UNII: 24H4NWX5CO)
TALC (UNII: 7SEV7J4R1U)
ZINC STEARATE (UNII: H92E6QA4FV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54312-925-01	1 in 1 PACKAGE	12/26/2017
1		80 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	09/30/2013

Labeler - Compania Internacional de Comercio, S.A.P.I. de C.V. (815039995)