Your browser does not support JavaScript! PROTECTIVE AND MOISTURIZING SKIN (CLOTRIMAZOLE) OIL [EDUARD GERLACH GMBH]
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PROTECTIVE AND MOISTURIZING SKIN (clotrimazole) oil
[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

Protective and Moisturizing Skin Oil

Drug Facts

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

  • Effectively treats most athlete's foot
  • cares for skin leaving it elastic and beautiful.

Warnings

For external use only.

When using this product

avoid contact with the eyes.

Stop use and ask a doctor if

  • There is no 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

Apply regularly 1-2 times daily and massage in for a few minutes until you can feel only a slight residue left. The nails and skin will recover and soon reveal their naturally healthy appearance.

Other information

Store between 20° to 25° C (68° to 77° F)

Inactive Ingredients

Isopropyl Myristate, Isopropyl Palmitate, Cocamide DEA, Alcohol denat., Triticum Vulgare (Wheat) Germ Oil, Laureth-2, Clotrimazol, Propylene Glycol, Panthenol, Bisabolol, Parfum, Undecylenamide DEA, Linalool

GEHWOL med. Protective and Moisturizing Skin Oil

Effectively treats most althlete's foot.

Cares for skin leaving it elastic and beautiful.

15ml 0.5 oz

Made in Germany

GEHWOL med Protective and Moisturizing Skin Oil, with wheatgerm oil, panthenol and bisabolol, cares for the skin, making it more supple and beacutiful and restoring its naturally healthy appearance.

Dermatologically tested.

image description

PROTECTIVE AND MOISTURIZING SKIN 
clotrimazole oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45264-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL PALMITATE 
ISOPROPYL MYRISTATE 
COCO DIETHANOLAMIDE 
WHEAT BRAN 
LAURETH-2 
ALCOHOL 
PANTHENOL 
PROPYLENE GLYCOL 
UNDECYLENIC ACID MONOETHANOLAMIDE 
LINALOOL, (+/-)- 
LEVOMENOL 
Packaging
#Item CodePackage Description
1NDC:45264-001-171 in 1 BOX
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/04/2008
Labeler - Eduard Gerlach GmbH (315343350)
Registrant - Eduard Gerlach GmbH (315343350)
Establishment
NameAddressID/FEIBusiness Operations
Eduard Gerlach GmbH315343350manufacture(45264-001)

Revised: 02/2013
Document Id: fc4cb0c5-f62d-49c8-b801-470dc4ad505e
Set id: e7d9cb10-d1d3-4306-955c-cfd95071d510
Version: 5
Effective Time: 20130214
 
Eduard Gerlach GmbH

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