Your browser does not support JavaScript! GEHWOL FUSSKRAFT NAIL AND SKIN PROTECTION (CLOTRIMAZOLE) SPRAY [EDUARD GERLACH GMBH]
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GEHWOL FUSSKRAFT NAIL AND SKIN PROTECTION (clotrimazole) spray
[Eduard Gerlach GmbH]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph 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

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

  • Shake can well before use.
  • Clean the affected area and dry thoroughly.
  • Spray a layer over the affected area twice daily (morning and night )

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:45264-008
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOBUTANE 
ALCOHOL 
ISOPROPYL MYRISTATE 
OCTYLDECANOL 
CASTOR OIL 
PANTHENOL 
LEVOMENOL 
UNDECYLENIC ACID 
.ALPHA.-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45264-008-5050 mL in 1 BOTTLE, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/18/2009
Labeler - Eduard Gerlach GmbH (315343350)
Registrant - Eduard Gerlach GmbH (315343350)
Establishment
NameAddressID/FEIBusiness Operations
Eduard Gerlach GmbH315343350manufacture(45264-008)

Revised: 2/2013
 
Eduard Gerlach GmbH

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