FDA Label for Clotrimazole
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - CONTAINER LABEL
- PRINCIPAL DISPLAY PANEL - CONTAINER CARTON LABEL
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.
Ask A Doctor Before Use
• on children under 2 years of age
When Using This Product
• avoid contact with eyes
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)
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 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)
Principal Display Panel - Container Carton Label
NDC 70010- 229-54
*Compare to the active ingredient in
Lotrimin ® AF
Athlete's Foot Solution
Clotrimazole
(Topical Solution),
USP
1%
Antifungal
• Relieves Itching & Burning
• Greaseless, Nonstanining
For External use only,
Not for Ophthalmic use.
Keep this and all medications
out of the reach of children.
10 mL (1/3 fl oz)
* Please review the disclaimer below.