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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Preferred Pharmaceuticals, Inc. for the product Clotrimazole (NDC 68788-0169). 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 other, active ingredients, purpose, uses, warnings, otc - do not use, ask a doctor before use if you have, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Clotrimazole 1% (50 mg in each applicatorful)
Clotrimazole 1% (external cream)
Vaginal antifungal
Vaginal antifungal
For vaginal use only
Do not use if you have never had a vaginal yeast infection diagnosed by a doctor
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate
1-800-432-8534 between 9 am and 4 pm EST, Monday- Friday.
45g tube - 68788-0169-4
Compare to the active ingredient
in Gyne-Lotrimin® Vaginal Cream*
Clotrimazole
Vaginal Cream, USP 1%
Vaginal Antifungal
Cures Most Vaginal Yeast Infections
1 Reusable Applicator (7-Day Therapy)
7-Day Treatment
ONE 45 g (1.5 OZ) Tube of Vaginal Cream (1%) and
1 Reusable Applicator (7-Day Therapy)
Educational Pamphlet Enclosed
* Please review the disclaimer below.