Package Label

Package Label
SPL v9
SPL
SPL Set ID 0ec760e8-fb33-423b-b3be-52fc09d18fd5
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 200 mg (in each suppository) Miconazole nitrate, USP 2% (external cream)


Medication Information

Warnings and Precautions

For vaginal use only

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: suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Throw applicator away after use. external cream: Use cap to puncture seal. Squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed. children under 12 years of age: ask a doctor

Description

Miconazole nitrate, USP 200 mg (in each suppository) Miconazole nitrate, USP 2% (external cream)

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

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

suppository: hydrogenated vegetable oil external cream: benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

Section 51945-4

Compare to the active ingredient in Monistat® 3* COMBINATION PACK Miconazole 3 Miconazole Nitrate Vaginal Suppositories, USP 200 mg & Miconazole Nitrate Vaginal Cream, USP Cream, USP 2% VAGINAL ANTIGUNGAL 3 - DAY TREATMENT Vaginal suppositories with 3 disposable applicators plus external cream for itch relief Cures most vaginal yeast infections Relieves associated external itching and irritation 3 MICONAZOLE NITRATE VAGINAL SUPPOSITORIES, USP 200 mg WITH 3 DISPOSABLE APPLICATORS PLUS 1 TUBE OF MICONAZOLE NITRATE VAGINAL CREAM, USP 2% NET WT OZ (g) *This product is not affiliated with, manufactured by, or produced by the makers or owners or Monistat®3. DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011 www.riteaid.com

Section 53413-1

Call 1 -877-753-3935 Monday-Friday 9AM-5PM EST

Section 53414-9

ask a health professional before use.

Section 55105-1

Vaginal antifungal   Vaginal antifungal

Section 55106-9

Miconazole nitrate, USP 200 mg (in each suppository) Miconazole nitrate, USP 2% (external cream)

Section 60561-8

do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped) do not use if seal over tube opening has been punctured or is not visible do not purchase if carton is open store at 20º-25ºC(68°-77°F) [see USP Controlled Room Temperature} excursions permitted to 15º-30ºC (59°- 86°F)


Structured Label Content

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: suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Throw applicator away after use. external cream: Use cap to puncture seal. Squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed. children under 12 years of age: ask a doctor

Warnings and Precautions (34071-1)

For vaginal use only

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

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)

suppository: hydrogenated vegetable oil external cream: 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® 3* COMBINATION PACK Miconazole 3 Miconazole Nitrate Vaginal Suppositories, USP 200 mg & Miconazole Nitrate Vaginal Cream, USP Cream, USP 2% VAGINAL ANTIGUNGAL 3 - DAY TREATMENT Vaginal suppositories with 3 disposable applicators plus external cream for itch relief Cures most vaginal yeast infections Relieves associated external itching and irritation 3 MICONAZOLE NITRATE VAGINAL SUPPOSITORIES, USP 200 mg WITH 3 DISPOSABLE APPLICATORS PLUS 1 TUBE OF MICONAZOLE NITRATE VAGINAL CREAM, USP 2% NET WT OZ (g) *This product is not affiliated with, manufactured by, or produced by the makers or owners or Monistat®3. DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011 www.riteaid.com

Section 53413-1 (53413-1)

Call 1 -877-753-3935 Monday-Friday 9AM-5PM EST

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Vaginal antifungal   Vaginal antifungal

Section 55106-9 (55106-9)

Miconazole nitrate, USP 200 mg (in each suppository) Miconazole nitrate, USP 2% (external cream)

Section 60561-8 (60561-8)

do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped) do not use if seal over tube opening has been punctured or is not visible do not purchase if carton is open store at 20º-25ºC(68°-77°F) [see USP Controlled Room Temperature} excursions permitted to 15º-30ºC (59°- 86°F)


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