DERMAN ANTIFUNGAL- zinc undecylenate cream

Derman Antifungal by

Drug Labeling and Warnings

Derman Antifungal by is a Otc medication manufactured, distributed, or labeled by Compania Internacional de Comercio, S.A.P.I de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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 (

54312-125-01)

Derman Antifungal (

54312-125-02)

INGREDIENTS AND APPEARANCE

DERMAN ANTIFUNGAL 
zinc undecylenate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54312-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	5 g  in 100 g
ZINC UNDECYLENATE (UNII: 388VZ25DUR) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	ZINC UNDECYLENATE	18 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BISULFITE (UNII: TZX5469Z6I)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
WATER (UNII: 059QF0KO0R)
ZINC STEARATE (UNII: H92E6QA4FV)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54312-125-01	1 in 1 CARTON	08/12/2013
1		25 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 54312-125-02	1 in 1 CARTON	08/12/2013
2		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	08/12/2013

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)

Establishment
Name	Address	ID/FEI	Business Operations
Compania Internacional de Comercio, S.A.P.I de C.V.		815039995	manufacture(54312-125)