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

Dosage form: spray
Ingredients: UNDECYLENIC ACID 100mg in 1mL
Labeler: Compania Internacional de Comercio, S.A. de C.V.
NDC Code: 54312-325

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 SPRAY SOLUTION

DERMAN ANTIFUNGAL SPRAY SOLUTION


Active ingredients

Undecylenic acid 10%

Purpose

Antifungal

Uses

For treatment of Athlete's Foot Relieves • itching • scaling • cracking • burning

Warnings

For external use only
Avoid contact with the eyes

Do not use

on children under 2 years of age unless directed by a doctor

If irritation

occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

Keep out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Wash the affected area and dry thoroughly. Apply a few drops 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. 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 and nails.

Inactive ingredients

ethyl alcohol, fdandc yellow no. 5

DERMAN ANTIFUNGAL SPRAY SOLUTION 35ml (54312-325-05)

DERMAN ANTIFUNGAL 
undecylenic acid spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54312-325
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:54312-325-051 BOTTLE (BOTTLE) in 1 PACKAGE
135 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/21/2013
Labeler - Compania Internacional de Comercio, S.A. de C.V. (815039995)
Establishment
NameAddressID/FEIOperations
Farmaqro, S.A. de C.V.588161468manufacture(54312-325)

Document Id: 1c651bfb-fdd9-4c2e-b5bb-243a1f703e18
Set id: 7cfcaac1-b210-4280-a48a-b3709d2b92e0
Version: 3
Effective Time: 20131024
 
Compania Internacional de Comercio, S.A. de C.V.

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Medically reviewed on Oct 24, 2018

Further information

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