FDA Label for Jock Itch
View Indications, Usage & Precautions
Jock Itch Product Label
The following document was submitted to the FDA by the labeler of this product The Ibn Sina Pharmaceutical Industry Ltd.. 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
Manufactured by:
The IBN SINA Pharmaceutical Industry Ltd.
Holding # A-80, Ward # 9, Shafipur, Kaliakoir
Gazipur-1751 Bangladesh
www.ibnsinapharma.com
Product of Bangladesh
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 72103-525-10
Jock Itch Cream
Clotrimazole Cream, USP 1%
Antifungal Cream
Net Wt. 0.35 oz (10g)
Cures Most Jock Itch
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