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

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Derman Antifungal

Active Ingredients.

Zinc undecylenate  18%

Undecylenic acid    5%

Purpose

Antifungal

Uses

For the treatment of athlete´s foot.

Warnings

For external use only

Do not use

on children under 2 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 the reach of children.

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

Directions

Inactive ingredients

Cetyl alcohol, Glycerin, Polyethylene Glycol 500, Polyethylene glycol 4000, Propylene glycol, Sodium bisulfite, Sodium laureth sulfate, water, Zinc stearate.

Derman Antifungal (54312-125-01)

LabelLabel2Label3Label4

Derman Antifungal (54312-125-02)

Outer Package3Inner Package3Outer Package4Inner Package4

DERMAN ANTIFUNGAL 
zinc undecylenate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54312-125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID5 g  in 100 g
ZINC UNDECYLENATE (UNII: 388VZ25DUR) (UNDECYLENIC ACID - UNII:K3D86KJ24N) ZINC UNDECYLENATE18 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BISULFITE (UNII: TZX5469Z6I)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
WATER (UNII: 059QF0KO0R)  
ZINC STEARATE (UNII: H92E6QA4FV)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54312-125-011 in 1 CARTON08/12/2013
125 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:54312-125-021 in 1 CARTON08/12/2013
250 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00508/12/2013
Labeler - Compania Internacional de Comercio, S.A.P.I de C.V. (822165213)
Registrant - 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(54312-125)

Revised: 10/2023
Document Id: 08c11d0d-600e-5641-e063-6394a90a1134
Set id: 0129d801-90f6-49fd-857f-27d6ba9fc66c
Version: 20
Effective Time: 20231028
 
Compania Internacional de Comercio, S.A.P.I de C.V.