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 Granules Pharmaceuticals Inc.. 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.

Active Ingredient



Clotrimazole USP, 1%


Purpose



Antifungal


Uses



Cures most
■ Athlete’s foot (tinea pedis)
■ Jock itch (tinea cruris)
■ Ringworm (tinea corporis)

Effectively relieves
■ itching
■ cracking
■ burning
■ discomfort which can accompany these conditions.


Warnings



For external use only.


Directions



  • ■ This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. 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



  • store between 15°-30°C (59°-86°F)

Inactive Ingredient



polyethylene glycol


Questions Or Comments?



call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST


Principal Display Panel - Container Label



NDC 70010- 229-54

Clotrimazole
(Topical Solution), USP

1%

Antifungal

For External use only,

not for Opthalmic use.

Keep this and all medications out

of the reach of children.

10 mL (1/3 fl oz)


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