DERMAN ANTIFUNGAL- zinc undecylenate, undecylenic acid powder

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.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

DERMAN ANTIFUNGAL- ZINC UNDECYLENATE, UNDECYLENIC ACID POWDER
COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I. DE C.V.
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DERMAN ANTIFUNGAL POWDER
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Undecylenic acid 2%
Zinc undecylenate 20%
_PURPOSE_
Antifungal
_USES_
• For the treatment of athlete's foot • Relieves • itching •
scaling • cracking • burning
_WARNINGS_
FOR EXTERNAL USE ONLY.
DO NOT USE
on children under 12 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 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 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 longer, consult a doctor.
This product is not effective on the scalp or nails.
_INACTIVE INGREDIENTS_
Fragrance, Koalin, Talc, Zinc Stearate
PACKAGE LABELING:
DERMAN ANTIFUNGAL POWDER, 80G (54312-925-01)
DERMAN ANTIFUNGAL
zinc undecylenate, undecylenic acid powder
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:54312-925
ROUTE OF ADMINISTRATION
TOPICAL
Compania Internacional de Comercio, S.A.P.I. de C.V.
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID -
UNII:K3D86KJ24N)
UNDECYLENIC ACID
2 g in 100 g
ZINC UNDECYLENATE (UNII: 388VZ25DUR) (UNDECYLENIC ACID -
UNII:K3D86KJ24N)
ZINC UNDECYLENATE
20 g
in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
KAOLIN (UNII: 24H4NWX5CO)
TALC (UNII: 7SEV7J4R1U)
ZINC STEARATE (UNII: H92E6QA4FV)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKE