GEHWOL NAIL PROTECTION PEN- clotrimazole liquid 
Eduard Gerlach GmbH

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:45264-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45264-009-211 in 1 BOX03/07/200804/12/2017
13 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/07/200804/12/2017
Labeler - Eduard Gerlach GmbH (315343350)
Registrant - Eduard Gerlach GmbH (315343350)
Establishment
NameAddressID/FEIBusiness Operations
Eduard Gerlach GmbH315343350manufacture(45264-009)

Revised: 4/2017
 
Eduard Gerlach GmbH