Other
Drug Facts
Manufactured by:
The IBN SINA Pharmaceutical Industry Ltd.
Holding # A-80, Ward # 9, Shafipur, Kaliakoir
Gazipur-1751 Bangladesh
www.ibnsinapharma.com
Product of Bangladesh
Clotrimazole
FDA Label NDC 72103-524
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Ibn Sina Pharmaceutical Industry Ltd. for the product Clotrimazole (NDC 72103-524). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Clotrimazole 1%
Otc - Purpose
Purpose
Antifungal
Indications & Usage
Uses
- cures most athlete's foot, jock itch and ringworm
- relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use on children under 2 years of age except under the advice and supervision of 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 improvement 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 (1-800-222-1222) right away.
Dosage & Administration
Directions
- wash the 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 the spaces between the toes
- wear well-fitting ventilated shoes
- 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 persists longer, consult a doctor
- this product is not effective on the scalp or nails
Storage And Handling
Other information
- store at 2° - 30° C (36° - 86° F)
- Lot No. & Exp. Date: see box or see crimp of tube
Inactive Ingredient
Inactive ingredients
cetostearyl alcohol, methylparaben, mineral oil, paraffin, polyoxyl 40 hydrogenated castor oil, polysorbate 80, water
Otc - Questions
Questions?
Call 1-833-IBN-SINA (1-833-426-7462)
Package Label.Principal Display Panel
NDC 72103-524-10
Clotrimazole Cream, USP 1%
Antifungal Cream
Net Wt. 0.35 oz (10g)
Cures Most Athlete's Foot, Jock Itch & Ringworm
Clotrimazole (Clotrimazole)
* Please review the disclaimer below.
