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Clotrimazole by Chain Drug Consortium, LLC

Medically reviewed on Dec 5, 2017

Dosage form: cream
Ingredients: CLOTRIMAZOLE 10mg in 1g
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-035

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.

Clotrimazole Cream-Antifungal

Drug Facts

Active ingredient

Clotrimazole, USP 1%

Purpose

Antifungal

Uses
  • cures most athlete’s foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling, and discomfort

Warnings

For external use only

Do not use

on children under 2 years of age, unless directed by a doctor.

When using this product
  • avoid contact with the eyes

Stop use and ask a doctor if
  • irritation occurs
  • there is no improvement within 4 weeks (for athlete’s foot and ringworm) or within 2 weeks (for jock itch)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • wash the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctor
  • supervise children in the use of this product
  • for athlete’s foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • for athlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition lasts longer, contact a doctor
  • this product is not effective on the scalp or nails

Other information
  • Store between 2°-30°C (36°-86°F).
  • Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

Principal Display Panel

Premier Value®

COMPARE TO THE ACTIVE INGREDIENT IN LOTRIMIN® AF*

Clotrimazole Cream, USP 1%
ANTIFUNGAL

Proven Clinically Effective in the Treatment of Most Athlete's Foot
Relieves: Itching ι Burning ι Cracking ι Scaling

NET WT 1 OZ (28g)

CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-035
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CETOSTEARYL ALCOHOL 
CETYL ESTERS WAX 
OCTYLDODECANOL 
POLYSORBATE 60 
WATER 
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS 
SORBITAN MONOSTEARATE 
Packaging
#Item CodePackage Description
1NDC:68016-035-061 TUBE in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C09/11/2003
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

 
Chain Drug Consortium, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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