DERMAN ANTIFUNGAL- undecylenic acid spray 
Compania Internacional de Comercio, S.A.P.I de C.V.

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DERMAN ANTIFUNGAL SPRAY SOLUTION

Drug Facts

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, fd and c yellow no. 5

Package Labeling:

Outer Label0Inner Label0

DERMAN ANTIFUNGAL 
undecylenic acid spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54312-325
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54312-325-051 in 1 PACKAGE10/21/2013
135 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00510/21/2013
Labeler - Compania Internacional de Comercio, S.A.P.I de C.V. (822165213)
Establishment
NameAddressID/FEIBusiness Operations
Compania Internacional de Comercio, S.A.P.I de C.V.822165213manufacture(54312-325)

Revised: 10/2023
Document Id: 08c13282-54a5-52a8-e063-6394a90a5c1d
Set id: 7cfcaac1-b210-4280-a48a-b3709d2b92e0
Version: 8
Effective Time: 20231028
 
Compania Internacional de Comercio, S.A.P.I de C.V.