FDA Label for Sunmark Clotrimazole
View Indications, Usage & Precautions
Sunmark Clotrimazole Product Label
The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services Llc. 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.
Other
Drug Facts
Distributed by McKesson
One Post Street
San Francisco, CA 94104
Active Ingredient
Clotrimazole USP, 1%
Purpose
Antifungal
Uses
- cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
- effectively relieves itching, cracking, burning and discomfort which can accompany these conditions
Warnings
For external use only
When Using This Product
- use only as directed
- 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 or ringworm) or 2 weeks (for jock itch)
Otc - Do Not Use
Do not use on children under 2 years of age except under the advice and supervision of a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- for best results, follow directions and continue treatment for length of time indicated
- to open, use pointed end on cap to puncture seal
- clean skin with soap and water and dry thoroughly
- apply a thin layer over affected area morning and evening
- 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
- best results in athlete's foot and ringworm are usually obtained with 4 weeks use, and in jock itch, with 2 weeks use. If satisfactory results have not occurred within these times, ask a doctor or pharmacist.
- children under 12 years of age should be supervised in the use of this product
- this product is not effective on the scalp or nails
Other Information
- store between 2°-30°C (36°-86°F)
- do not use if seal on tube is broken or is not visible
- See box or tube crimp for lot number and expiration date.
Inactive Ingredients
benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate
Principal Display Panel - 30 G Tube Carton
sunmark™
antifungal cream
Clotrimazole Cream USP, 1%
CURES MOST ATHLETE'S FOOT
NET WT 1 OZ (30 g)
* Please review the disclaimer below.