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Review RxNorm Normal Forms

GEHWOL NAIL PROTECTION PEN (clotrimazole) liquid
[Eduard Gerlach GmbH]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=fefa7ab3-814d-47b8-a890-a732bcb70b53

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph not 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.

Drug Label Sections

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 me Nail Protection Pen

Clotrimazole 1%

Purpose

Antifungal

Uses

Protects against fungal infection
Brittle and dry nails becomes supple.
Help to gain natural silk sheen.

Warning

For external use only.

When using this product

avoid contact with eyes

Stop use and ask a doctor

If redness or irritation develops

Keep out of reach of children

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

Directions

Apply regularly over the nail once or twice daily so that the nail is moistened all over

Other Information

Store at 20-25° C (68°-77° F)

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 NAIL PROTECTION PEN
clotrimazole liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45264-009
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (CLOTRIMAZOLE)	CLOTRIMAZOLE	10 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL MYRISTATE
ISOPROPYL PALMITATE
COCO DIETHANOLAMIDE
ALCOHOL
JOJOBA OIL
LAURETH-2
PROPYLENE GLYCOL
PANTHENOL
.ALPHA.-TOCOPHEROL ACETATE
LEVOMENOL
WATER

Packaging
#	Item Code	Package Description
1	NDC:45264-009-21	1 in 1 BOX
1		3 mL in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333C	03/07/2008

Labeler - Eduard Gerlach GmbH (315343350)

Registrant - Eduard Gerlach GmbH (315343350)

Establishment
Name	Address	ID/FEI	Business Operations
Eduard Gerlach GmbH		315343350	manufacture(45264-009)

Revised: 02/2013

Document Id: f48c9a18-03b7-4183-a764-95daed36b4e2

Set id: fefa7ab3-814d-47b8-a890-a732bcb70b53

Version: 2

Effective Time: 20130214

Eduard Gerlach GmbH

Daily Med

Current Medication Information

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