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

Dosage form: powder
Ingredients: UNDECYLENIC ACID 2g in 100g, ZINC UNDECYLENATE 20g in 100g
Labeler: Compania Internacional de Comercio, S.A.P.I. de C.V.
NDC Code: 54312-925

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 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
  • Wash the affected area and dry thoroughly.
  • Apply a thin layer 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.
  • 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 longer, consult a doctor.
  • This product is not effective on the scalp or nails.

Inactive ingredients

Fragrance, Koalin, Talc, Zinc Stearate

Package Labeling:

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

DERMAN ANTIFUNGAL 
zinc undecylenate, undecylenic acid powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54312-925
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID2 g  in 100 g
ZINC UNDECYLENATE (UNDECYLENIC ACID) ZINC UNDECYLENATE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
KAOLIN 
TALC 
ZINC STEARATE 
Packaging
#Item CodePackage Description
1NDC:54312-925-011 BOTTLE in 1 PACKAGE
180 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/30/2013
Labeler - 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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Medically reviewed on Jun 13, 2018

Further information

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

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