package label

package label
SPL v15
SPL
SPL Set ID 7b1005e1-52ab-41f6-a180-72ab2b725fea
Route
vaginal
Published
Effective Date 2025-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Miconazole nitrate, USP 2% (100 mg in each applicator)


Medication Information

Warnings and Precautions

For vaginal use only

Active Ingredient

Miconazole nitrate, USP 2% (100 mg in each applicator)

Indications and Usage

treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection

Dosage and Administration

before using this product read the enclosed consumer information leaflet for complete directions and information adults and children 12 years of age and over: ● applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw applicator away after use. ● 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

Description

Miconazole nitrate, USP 2% (100 mg in each applicator)

Section 42229-5

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) before using any medication, read all label directions, keep carton, it contains important information.

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

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

Section 50567-7

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.

Section 50568-5

taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

Section 50569-3

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

Section 50570-1

if you have never had a vaginal yeast infection diagnosed by a doctor

Section 51727-6

benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

Section 51945-4

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 7 - DAY TREATMENT Cures most vaginal yeast infections Relieves associated external itching and irritation NET WT OZ (g) Tube *This product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat® DISTRIBUTED BY: RITE AID, 200 NEWBERRY COMMONS ETTERS, PA 17319

Section 53413-1

Call 1- 877-735-3935 Monday-Friday 9AM-5PM EST

Section 53414-9

ask a health professional before use.

Section 55105-1

Vaginal antifungal


Structured Label Content

Warnings and Precautions (34071-1)

For vaginal use only

Active Ingredient (55106-9)

Miconazole nitrate, USP 2% (100 mg in each applicator)

Indications and Usage (34067-9)

treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection

Dosage and Administration (34068-7)

before using this product read the enclosed consumer information leaflet for complete directions and information adults and children 12 years of age and over: ● applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw applicator away after use. ● 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

Section 42229-5 (42229-5)

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) before using any medication, read all label directions, keep carton, it contains important information.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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.

Section 50568-5 (50568-5)

taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

if you have never had a vaginal yeast infection diagnosed by a doctor

Section 51727-6 (51727-6)

benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

Section 51945-4 (51945-4)

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 7 - DAY TREATMENT Cures most vaginal yeast infections Relieves associated external itching and irritation NET WT OZ (g) Tube *This product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat® DISTRIBUTED BY: RITE AID, 200 NEWBERRY COMMONS ETTERS, PA 17319

Section 53413-1 (53413-1)

Call 1- 877-735-3935 Monday-Friday 9AM-5PM EST

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Vaginal antifungal


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