GEHWOL FUSSKRAFT NAIL AND SKIN PROTECTION- clotrimazole spray 
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 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

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 (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 4 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ISOBUTANE (UNII: BXR49TP611)  
ALCOHOL (UNII: 3K9958V90M)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
OCTYLDECANOL (UNII: 07UG7TSU58)  
CASTOR OIL (UNII: D5340Y2I9G)  
PANTHENOL (UNII: WV9CM0O67Z)  
LEVOMENOL (UNII: 24WE03BX2T)  
UNDECYLENIC ACID (UNII: K3D86KJ24N)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
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: 2/2013
Document Id: df1175ef-6692-4c0c-9642-278c2e42de49
Set id: 2c301c99-d58b-4d77-9ae1-bec6d8bf136f
Version: 2
Effective Time: 20130214
 
Eduard Gerlach GmbH