DERMAN ANTIFUNGAL- zinc undecylenate cream

DERMAN ANTIFUNGAL by

Drug Labeling and Warnings

DERMAN ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by Teresa Cecena DBA Genesis, Teresa Cecena, COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I.DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS.

Zinc undercylenate 18%

undecylenic acid 5%

PURPOSE

PURPOSE

Antifungal

USER SAFETY WARNINGS

USES

For the treatment of athlete's foot. Relieves itching-scaling-cracking-buring.

WARNINGS

AVOID CONTACT WITH EYES

Keep this and all drugs out od the reach of children. In case of accidental ingestion. seel professional assistance or contact a poison control center immediately.

DO NOT USE

Do not use in pregnancy and children under 2 years of age unless directed by a physician.

For external use only

In case of accidental ingestion seek professional assistance or contac a poison control center immediately.

DOSAGE & ADMINISTRATION

Wash the affected area and dry throughly. Appy a thin layer of the product over the affected area ttwice daily ( morning and night) or as directed by a physician. Supervise children in the use of this product Pay special attention to space between the toes, wear well fitting, ventilated shoes. 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 INGREDIENT

Polyethylene Glyctol 500, polythylene glycol 4000, water, glycerin, cetyl alcohol, propylene, gycol, zinc stearate, nonyl phenol sulfate, sodium bisulfite.

PRINCIPAL DISPLAY PANEL

KEEP OUT OF REACH OF CHILDREN

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Wash the affected area and dry throughly. Appy a thin layer of the product over the affected area ttwice daily ( morning and night) or as directed by a physician. Supervise children in the use of this product Pay special attention to space between the toes, wear well fitting, ventilated shoes. 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

INGREDIENTS AND APPEARANCE

DERMAN ANTIFUNGAL 
zinc undecylenate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69772-125
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
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ZINC STEARATE (UNII: H92E6QA4FV)
SODIUM BISULFITE (UNII: TZX5469Z6I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69772-125-02	1 in 1 CARTON	05/14/2015
1	NDC: 69772-125-01	25 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69772-125-03	1 in 1 CARTON	05/20/2015
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	05/14/2015

Labeler - Teresa Cecena DBA Genesis (078760958)

Registrant - Teresa Cecena (078760958)

Establishment
Name	Address	ID/FEI	Business Operations
Teresa Cecena DBA Genesis		078760958	relabel(69772-125)

Establishment
Name	Address	ID/FEI	Business Operations
COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I.DE C.V.		815039995	manufacture(69772-125)