PROTECTIVE AND MOISTURIZING SKIN- clotrimazole oil 
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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Protective and Moisturizing Skin Oil

Drug Facts

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

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 Type HUMAN OTC DRUG Item Code (Source) NDC:45264-001
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 PALMITATE (UNII: 8CRQ2TH63M)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
WHEAT BRAN (UNII: 6L966A1IMR)  
LAURETH-2 (UNII: D4D38LT1L5)  
ALCOHOL (UNII: 3K9958V90M)  
PANTHENOL (UNII: WV9CM0O67Z)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
UNDECYLENIC ACID MONOETHANOLAMIDE (UNII: 9870N09I68)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LEVOMENOL (UNII: 24WE03BX2T)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:45264-001-18 1 in 1 BOX
1 50 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 12/04/2008
Labeler - Eduard Gerlach GmbH (315343350)
Registrant - Eduard Gerlach GmbH (315343350)
Establishment
Name Address ID/FEI Business Operations
Eduard Gerlach GmbH 315343350 manufacture(45264-001)

Revised: 11/2014
Document Id: 5729a3b0-f19a-4fa5-9445-ba20a8d56e1e
Set id: e7d9cb10-d1d3-4306-955c-cfd95071d510
Version: 6
Effective Time: 20141110
 
Eduard Gerlach GmbH