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Quality Choice Clotrimazole

Dosage form: cream
Ingredients: CLOTRIMAZOLE 10mg in 1g
Labeler: Chain Drug Marketing Association
NDC Code: 63868-595

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.

Active ingredient                                                                     Purpose

Clotrimazole 1%.................................................................. Antifungal

Uses

  • cures most athlete's foot, jock itch, and ringworm

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 iprovement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toesl; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Other information

  • store between 20° to 25°C (68° to 77°F)
  • Lot No. & Exp. Date: see box or see crimp of tube

Inactive ingredients benzyl alcohol, cetanol, liquid paraffin, octyldodecanol, polysorbate 60, propylene glycol, purified water, sodium hydroxide, sodium monostearate, stearic acid, stearyl alcohol

DISTRIBUTED BY C.D.M.A., INC.

43157 W. NINE MILE

NOVI, MI 48376-0995

www.qualitychoice.com

MADE IN KOREA

QUALITY CHOICE CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-595
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 
PARAFFIN 
OCTYLDODECANOL 
POLYSORBATE 60 
PROPYLENE GLYCOL 
WATER 
SODIUM HYDROXIDE 
STEARIC ACID 
STEARYL ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:63868-595-281 TUBE in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/19/2015
Labeler - Chain Drug Marketing Association (011920774)

 
Chain Drug Marketing Association

Medically reviewed on Jan 22, 2018

Further information

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

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