Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL - 45 g Tube Carton 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 H 2 pharma Relabeled By: Preferred Pharmaceuticals Inc. Miconazole Nitrate Vaginal Cream 2%
- PRINCIPAL DISPLAY PANEL - 45 g Tube Carton 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 H 2 pharma Relabeled By: Preferred Pharmaceuticals Inc. Miconazole Nitrate Vaginal Cream 2%
Overview
Uses • treats vaginal yeast infections • relieves external itching and irritation due to a vaginal yeast infection
Indications & Usage
Uses • treats vaginal yeast infections • relieves external itching and irritation due to a vaginal yeast infection
Dosage & Administration
Directions • before using this product read the enclosed consumer information leaflet for complete directions and information • adults and children 12 years of age and over: o applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use. o use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days as needed. • children under 12 years of age: ask a doctor
Warnings & Precautions
Warnings For vaginal use only Do not use if you have never had a vaginal yeast infection diagnosed by a doctor. Ask a doctor before use if you have • vaginal itching and discomfort for the first time • lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. • vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. • been exposed to the human immunodeficiency virus (HIV) that causes AIDS Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur. When using this product • do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). • do not have vaginal intercourse • mild increase in vaginal burning, itching or irritation may occur • if you do not get complete relief ask a doctor before using another product Stop use and ask a doctor if • symptoms do not get better in 3 days • symptoms last more than 7 days • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge 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.
Purpose
Purpose Vaginal antifungal
Do Not Use
Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.
When Using
When using this product • do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). • do not have vaginal intercourse • mild increase in vaginal burning, itching or irritation may occur • if you do not get complete relief ask a doctor before using another product
Stop Use & Ask a Doctor
Stop use and ask a doctor if • symptoms do not get better in 3 days • symptoms last more than 7 days • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
Keep Out of Reach of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Storage & Handling
Other information • to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use • do not use if foil seal on tube opening is broken or missing • do not purchase if carton is open • store at room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F) • before using any medication, read all label directions. Keep carton, it contains important information.
Questions
Questions? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
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