Miconazole 7
99c66cbd-7063-4b4c-b827-4f2fcb6ed67f
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Purpose
Vaginal antifungal
Medication Information
Purpose
Vaginal antifungal
Description
Drug Facts
Uses
-
•treats vaginal yeast infections
-
•relieves external itching and irritation due to a vaginal yeast infection
Section 42229-5
Drug Facts
Section 50565-1
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Section 50568-5
Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur.
Section 50570-1
Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Warnings
For vaginal use only
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:
-
oapplicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use.
-
ouse 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
Questions?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Active Ingredient
Miconazole nitrate USP, 2% (100 mg in each applicator)
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.
Inactive Ingredients
benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water
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
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
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
H2pharma
Relabeled By: Preferred Pharmaceuticals Inc.
Structured Label Content
Uses
-
•treats vaginal yeast infections
-
•relieves external itching and irritation due to a vaginal yeast infection
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur.
Section 50570-1 (50570-1)
Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Purpose
Vaginal antifungal
Warnings
For vaginal use only
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:
-
oapplicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use.
-
ouse 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
Questions?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Active Ingredient (Active ingredient)
Miconazole nitrate USP, 2% (100 mg in each applicator)
Other Information (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.
Inactive Ingredients (Inactive ingredients)
benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water
When Using This Product (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 (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
Ask A Doctor Before Use If You Have (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
Principal Display Panel 45 G Tube Carton (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
H2pharma
Relabeled By: Preferred Pharmaceuticals Inc.
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Raw Label Data
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Source: dailymed · Ingested: 2026-02-15T12:06:45.359640 · Updated: 2026-03-14T23:09:41.311223