Active Ingredients
Clotrimazole, USPÂ 1%
)
Clotrimazole
FDA Label NDC 36800-508
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Top Care (topco Associates Llc) for the product Clotrimazole (NDC 36800-508). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, when using this product,, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
- treats 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 foots 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 (1-800-222-1222) 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 at room temperature 20°-25°C (68°-77°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
Question Or Comments?
Call toll free 1-888-423-0139
Principal Display Panel
COMPARE TO LOTRIMIN® AF ATHLETE'S FPPT CREAM ACTIVE INGREDIENT*
Athlete's Foot Cream
Cure Most Athlete's Foot
RELIEVES:
- Itching
- Burning
- Cracking
- Scaling
- Proven Clinically Effective in the Treatment of Most Athlete's Foot
- Soothes Itching and Burning
NET WT. OZ (g)
*This product is not manufactured or distributed by Bayer HealthCare LLC., distributor of Lotrimin® AF Athlete's Foot Cream.
DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
Package Label
TOPCARE HEALTH Athlete's Foot Cream
* Please review the disclaimer below.
