Active Ingredient
Clotrimazole USP, 1%
Clotrimazole Solution
FDA Label NDC 70010-229
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Granules Pharmaceuticals Inc. for the product Clotrimazole (NDC 70010-229). 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 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., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
Clotrima-container (Clotrima Container)
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)
Clotrima-carton (Clotrima Carton)
* Please review the disclaimer below.
