FDA Label for Clotrimazole
View Indications, Usage & Precautions
Clotrimazole Product Label
The following document was submitted to the FDA by the labeler of this product Central Texas Community Health Centers. 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:
Taro Pharmaceuticals
U.S.A., Inc.
Hawthorne, NY 10532
Active Ingredient
Clotrimazole 1%
Purpose
Antifungal
Uses
- cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
- for effective relief of
- itching
- scaling
- cracking
- burning
- redness
- soreness
- irritation
- discomfort
Warnings
For external use only
Otc - Ask Doctor
Ask a doctor before use
- on children under 2 years of age
Otc - When Using
When using this product
- avoid contact with 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 within 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 right away.
Directions
This product is not effective on the scalp or nails.
For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
- clean 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; change shoes and socks at least once daily
Other Information
- To open: unscrew cap, use the pointed end of cap to puncture seal.
- store between 2°- 30°C (36° - 86°F)
- see carton 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
Questions?
Call 1-866-923-4914
How Supplied
Product: 76413-351
NDC: 76413-351-30 30 g in a TUBE / 1 in a CARTON
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