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

Dosage form: cream
Ingredients: ZINC UNDECYLENATE 18g in 100g, UNDECYLENIC ACID 5g 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 athletes foot.

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 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

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

Package Labeling:

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
ZINC UNDECYLENATE (UNDECYLENIC ACID) ZINC UNDECYLENATE18 g  in 100 g
UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN 
POLYETHYLENE GLYCOL 500 
POLYETHYLENE GLYCOL 4000 
GLYCERIN 
CETYL ALCOHOL 
PROPYLENE GLYCOL 
WATER 
ZINC STEARATE 
SODIUM BISULFITE 
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 finalpart333C12/26/2017
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)

Revised: 12/2017
 
Compania Internacional de Comercio, S.A.P.I de C.V.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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