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Derman Antifungal by Compania Internacional de Comercio, S.A.P.I de C.V.

Medically reviewed on Jun 13, 2018

Dosage form: cream
Ingredients: UNDECYLENIC ACID 5g in 100g, ZINC UNDECYLENATE 18g in 100g
Labeler: Compania Internacional de Comercio, S.A.P.I de C.V.
NDC Code: 54312-125

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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
  • Wash the affected area and dry thoroughly. 
  • Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor. 
  • Supervise children in the use of this product. 
  • For athlete's foot: 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, consults a physician. 
  • This product is not effective on the scalp or nails.

Inactive ingredients

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

Derman

Antifungal Cream

FOR THE TREATMENT OF ATHLETE´S FOOT

Zinc Undecylenate Undecylenic acid

MANUFACTURED BY FARMAQRO, S.A. de C.V., CALLE 2 NO. 42, PARQUE INDUSTRIAL BENITO JUÁREZ, SANTIAGO DE QUERÉTARO, QRO. C.P. 76120 DISTRIBUTED BY VITACILINA CORPORATION OF AMERICA, McALLEN,TX. 78501 MADE IN MEXICO

Derman Antifungal Cream, 25g (54312-125-01)

Derman Antifungal Cream, 50g (4312-125-02)

DERMAN ANTIFUNGAL 
zinc undecylenate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54312-125
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID5 g  in 100 g
ZINC UNDECYLENATE (UNDECYLENIC ACID) ZINC UNDECYLENATE18 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
GLYCERIN 
POLYETHYLENE GLYCOL 500 
POLYETHYLENE GLYCOL 4000 
PROPYLENE GLYCOL 
SODIUM BISULFITE 
SODIUM LAURETH SULFATE 
WATER 
ZINC STEARATE 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:54312-125-011 TUBE in 1 CARTON
125 g in 1 TUBE
2NDC:54312-125-021 TUBE in 1 CARTON
250 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/12/2013
Labeler - Compania Internacional de Comercio, S.A.P.I de C.V. (815039995)
Registrant - Compania Internacional de Comercio, S.A.P.I de C.V. (815039995)

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

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Further information

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

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