FDA Label for Quality Choice Clotrimazole

View Indications, Usage & Precautions

Quality Choice Clotrimazole Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredient                                                                     Purpose

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


Otc - Purpose



Uses

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

Warnings



Warnings

For external use only


Otc - Do Not Use



Do not use on children under 2 years of age unless directed by a doctor


Otc - When Using



When using this product avoid contact with the eyes


Otc - Stop Use



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)

Otc - Keep Out Of Reach Of Children



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


Indications & Usage



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

Storage And Handling



Other information

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

Inactive Ingredient



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


Dosage & Administration



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

43157 W. NINE MILE

NOVI, MI 48376-0995

www.qualitychoice.com

MADE IN KOREA


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