DERMAN ANTIFUNGAL

Dosage form: spray
Ingredients: UNDECYLENIC ACID 100mg in 1mL
Labeler: Compania Internacional de Comercio, S.A. de C.V.
NDC code: 54312-325

Medically reviewed by Drugs.com. Last updated on Nov 6, 2023.

DERMAN ANTIFUNGAL SPRAY SOLUTION

Active ingredients

Undecylenic acid 10%

Purpose

Antifungal

Uses

For treatment of Athlete's Foot Relieves • itching • scaling • cracking • burning

Warnings

For external use only
Avoid contact with the eyes

Do not use

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

If irritation

occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

Keep out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Wash the affected area and dry thoroughly. Apply a few drops 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. 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 and nails.

Inactive ingredients

ethyl alcohol, fdandc yellow no. 5

DERMAN ANTIFUNGAL SPRAY SOLUTION 35ml (54312-325-05)

DERMAN ANTIFUNGAL
undecylenic acid spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54312-325
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNDECYLENIC ACID)	UNDECYLENIC ACID	100 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL
FD&C YELLOW NO. 5

Packaging
#	Item Code	Package Description
1	NDC:54312-325-05	1 BOTTLE in 1 PACKAGE
1		35 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	10/21/2013

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

Establishment
Name	Address	ID/FEI	Operations
Farmaqro, S.A. de C.V.		588161468	manufacture(54312-325)

Document Id: 9752d826-6b67-0e2e-e053-2995a90a2853

Set id: 7cfcaac1-b210-4280-a48a-b3709d2b92e0

Version: 4

Effective Time: 20191114

Compania Internacional de Comercio, S.A. de C.V.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer