DERMAN ANTIFUNGAL- zinc undecylenate cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N), ZINC UNDECYLENATE (UNII: 388VZ25DUR) (UNDECYLENIC ACID - UNII:K3D86KJ24N)

Available from:

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

INN (International Name):

ZINC UNDECYLENATE

Composition:

ZINC UNDECYLENATE 18 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

For the treatment of athlete´s foot.

Authorization status:

OTC monograph final

Summary of Product characteristics

DERMAN ANTIFUNGAL- ZINC UNDECYLENATE CREAM
COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.
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DERMAN ANTIFUNGAL
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)
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: