DERMAN ANTIFUNGAL- undecylenic acid spray

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]

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)

INGREDIENTS AND APPEARANCE

DERMAN ANTIFUNGAL 
undecylenic acid spray

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54312-325-05	1 in 1 PACKAGE	10/21/2013
1		35 mL 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	10/21/2013

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

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