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Drug Facts
Distributed by: H2-Pharma, LLC
Montgomery, AL 36117
Relabeled By: Preferred Pharmaceuticals Inc.
The following Structured Product Label (SPL) was submitted to the FDA by Preferred Pharmaceuticals Inc. for the product Miconazole 7 (NDC 68788-7917). 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 ingredient, purpose, uses, warnings, otc - do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Distributed by: H2-Pharma, LLC
Montgomery, AL 36117
Relabeled By: Preferred Pharmaceuticals Inc.
Miconazole nitrate USP, 2% (100 mg in each applicator)
Vaginal antifungal
For vaginal use only
Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.
Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur.
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.
benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
NDC 68788-7917-4
*Compare to the active ingredient in
Monistat® 7 Vaginal Cream
Miconazole 7
Miconazole Nitrate Vaginal Cream, USP 2%
(Miconazole Nitrate 100 mg per applicator)
Vaginal Antifungal
Cures most vaginal yeast infections
Relieves associated external itching and irritation
Net wt. 1.59 oz (45 g) Tube
7 day vaginal cream (1 tube) with 1 reusable applicator
H2pharma
Relabeled By: Preferred Pharmaceuticals Inc.
* Please review the disclaimer below.