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

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DERMAN ANTIFUNGAL POWDER

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

Inactive ingredients

Fragrance, Koalin, Talc, Zinc Stearate

Package Labeling:

Label3

Derman Antifungal Powder, 80g (54312-925-01)

Outer Package 03Inner Package 03

DERMAN ANTIFUNGAL 
zinc undecylenate, undecylenic acid powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54312-925
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID2 g  in 100 g
ZINC UNDECYLENATE (UNII: 388VZ25DUR) (UNDECYLENIC ACID - UNII:K3D86KJ24N) ZINC UNDECYLENATE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
KAOLIN (UNII: 24H4NWX5CO)  
TALC (UNII: 7SEV7J4R1U)  
ZINC STEARATE (UNII: H92E6QA4FV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54312-925-011 in 1 PACKAGE12/26/2017
180 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00509/30/2013
Labeler - Compania Internacional de Comercio, S.A.P.I. de C.V. (822165213)

Revised: 10/2023
Document Id: 08c12b68-e06d-3c2e-e063-6294a90a9998
Set id: 6169af3c-cc90-484d-a0f5-14f5f9ae0a6f
Version: 13
Effective Time: 20231028
 
Compania Internacional de Comercio, S.A.P.I. de C.V.