GEHWOL NAIL PROTECTION PEN- clotrimazole liquid 
Eduard Gerlach GmbH

Disclaimer: 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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Gehwol me Nail Protection Pen

Clotrimazole 1%

Purpose

Antifungal

Uses

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:45264-009
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL MYRISTATE 
ISOPROPYL PALMITATE 
COCO DIETHANOLAMIDE 
ALCOHOL 
JOJOBA OIL 
LAURETH-2 
PROPYLENE GLYCOL 
PANTHENOL 
.ALPHA.-TOCOPHEROL ACETATE 
LEVOMENOL 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45264-009-211 in 1 BOX
13 mL in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333C03/07/2008
Labeler - Eduard Gerlach GmbH (315343350)
Registrant - Eduard Gerlach GmbH (315343350)
Establishment
NameAddressID/FEIBusiness Operations
Eduard Gerlach GmbH315343350manufacture(45264-009)

Revised: 2/2013
Document Id: f48c9a18-03b7-4183-a764-95daed36b4e2
Set id: fefa7ab3-814d-47b8-a890-a732bcb70b53
Version: 2
Effective Time: 20130214
 
Eduard Gerlach GmbH