DERMAN - undecylenic acid solution
Compania Internacional de Comercio, S.A. de C.V.

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.

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Active Ingredients

Undecylenic acid 10%

Purpose

Antifungal

For the treatment of athlete's foot Relieves itching scaling cracking burning

For external use only

Avoid contact with 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 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 fd and c yellow no. 5

DERMAN ANTIFUNGAL SPRAY SOLUTION

FOR THE TREATMENT OF ATHLETE'S FOOT

RELIEVES ITCHING SCALING CRACKING BURNING

1.18 FL OZ (35 ml)

DERMAN
undecylenic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54312-425
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNDECYLENIC ACID)	UNDECYLENIC ACID	10 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:54312-425-05	34 g in 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	08/27/2012	11/28/2012

Labeler - Compania Internacional de Comercio, S.A. de C.V. (822165213)

Establishment
Name	Address	ID/FEI	Operations
BONARUM PHARMA S.A. de C.V.		815029384	manufacture

Revised: 11/2012 Compania Internacional de Comercio, S.A. de C.V.