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GEHWOL FUSSKRAFT NAIL AND SKIN PROTECTION (clotrimazole) spray
[Eduard Gerlach GmbH]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2c301c99-d58b-4d77-9ae1-bec6d8bf136f

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph final

NOTE: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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Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Gehwol FUSSKRAFT Nail and Skin Protection Spray

Active ingredient

Clotrimazole 0,4%

Purpose

Antifungal

Uses

• Effectively treats most athlete‘s foot

• Cares for skin leaving it elastic and beautiful.

• Gehwol Fusskraft Foot Spray with panthenol and vitamin E, helps improve elasticity and stablility of the skin.

• Clotrimazol effectively treats most athlete‘s foot. The dosing valve distributes exactly the right quantity of oil between the toes.

Warning

For external use only.

When using this product

avoid contact with the eyes

Stop use and ask a Doctor if

There is not improvement within 4 weeks.
Irritation occurs.

Do not use on children

Under 2 years of age unless directed by a Doctor.

Keep out of reach of children

if swallowed get medical help or contact a poison control center right away

Directions

Shake can well before use.
Clean the affected area and dry thoroughly.
Spray a layer over the affected area twice daily (morning and night )

Other Information

Protect from sunlight and do not expose to temperatures exceeding 120°F (50° C)

Do not pierce or burn, even after use. Do not spray on a naked flame or any incandescent material. Keep away from source of ignition-no smoking

Inactive Ingredients

Isobutane, Alcohol denat, Isopropyl Myristate, Octyldodecanol, PEG-40 Hydrogenated Castor Oil, Panthenol, Bisabolol, Aqua (Water), Parfum (Fragrance), Undecylenamide DEA, Tocopheryl Acetate, Propylene Glycol

image description

GEHWOL FUSSKRAFT NAIL AND SKIN PROTECTION
clotrimazole spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45264-008
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (CLOTRIMAZOLE)	CLOTRIMAZOLE	4 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOBUTANE
ALCOHOL
ISOPROPYL MYRISTATE
OCTYLDECANOL
CASTOR OIL
PANTHENOL
LEVOMENOL
UNDECYLENIC ACID
.ALPHA.-TOCOPHEROL ACETATE

Packaging
#	Item Code	Package Description
1	NDC:45264-008-50	50 mL in 1 BOTTLE, UNIT-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	06/18/2009

Labeler - Eduard Gerlach GmbH (315343350)

Registrant - Eduard Gerlach GmbH (315343350)

Establishment
Name	Address	ID/FEI	Business Operations
Eduard Gerlach GmbH		315343350	manufacture(45264-008)

Revised: 02/2013

Document Id: df1175ef-6692-4c0c-9642-278c2e42de49

Set id: 2c301c99-d58b-4d77-9ae1-bec6d8bf136f

Version: 2

Effective Time: 20130214

Eduard Gerlach GmbH

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