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 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 (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 10 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
ALCOHOL (UNII: 3K9958V90M)  
JOJOBA OIL (UNII: 724GKU717M)  
LAURETH-2 (UNII: D4D38LT1L5)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PANTHENOL (UNII: WV9CM0O67Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LEVOMENOL (UNII: 24WE03BX2T)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
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: 2/2013
Document Id: f48c9a18-03b7-4183-a764-95daed36b4e2
Set id: fefa7ab3-814d-47b8-a890-a732bcb70b53
Version: 2
Effective Time: 20130214
 
Eduard Gerlach GmbH