Monistat 3 Combination Pack_ovule Inserts-tube_63736-019-03
910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Fa c ts
Purpose
Vaginal antifungal Vaginal antifungal
Medication Information
Purpose
Vaginal antifungal
Vaginal antifungal
Description
Drug Fa c ts
A
Miconazole nitrate (200 mg in each vaginal insert)
Miconazole nitrate 2% (external cream)
Uses
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
Section 42229-5
Drug Fa c ts
Other I
- do not use if printed sealed pouches containing vaginal inserts are torn, open or incompletely sealed
- do not use if seal over tube opening has been punctured
- do not purchase if carton is open
- store at 20°-25°C (68°-77°F)
- Keep this carton for future reference. It contains important information.
Inactive
vaginal insert: gelatin, glycerin, hydrogenated vegetable oil base, titanium dioxide
external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol
Warnings
For vaginal use only
Questions
If you have any questions or comments, please call 1-877-666-4782 .
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:
▪ vaginal insert : with a disposable applicator, place the insert into the vagina at bedtime for three nights in a row. Throw applicator away after use.
▪ external cream : squeeze a small amount of cream onto your fingertip. 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.
Do Not Use
if you have never had a vaginal yeast infection diagnosed by a doctor
Ask A Doctor Or P
taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur.
Keep Out of Reach Of
If swallowed, get medical help or contact a Poison Control Center right away.
Principal Display Panel
MONISTAT
®
3
COMBINATION PACK
Miconazole Nitrate Vaginal Inserts (200 mg) and
Miconazole Nitrate Vaginal Cream (2%) – Vaginal Antifungal
3 OVULE® Inserts Net Wt. 2.5 g each
+ 0.32 oz (9 g) Tube
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
If Pregnant Or Breast Feeding
ask a health professional before use.
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, v omiting, 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
Structured Label Content
A
Miconazole nitrate (200 mg in each vaginal insert)
Miconazole nitrate 2% (external cream)
Uses
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
Section 42229-5 (42229-5)
Drug Fa c ts
Other I (Other i)
- do not use if printed sealed pouches containing vaginal inserts are torn, open or incompletely sealed
- do not use if seal over tube opening has been punctured
- do not purchase if carton is open
- store at 20°-25°C (68°-77°F)
- Keep this carton for future reference. It contains important information.
Purpose
Vaginal antifungal
Vaginal antifungal
Inactive
vaginal insert: gelatin, glycerin, hydrogenated vegetable oil base, titanium dioxide
external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol
Warnings
For vaginal use only
Questions
If you have any questions or comments, please call 1-877-666-4782 .
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:
▪ vaginal insert : with a disposable applicator, place the insert into the vagina at bedtime for three nights in a row. Throw applicator away after use.
▪ external cream : squeeze a small amount of cream onto your fingertip. 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.
Do Not Use (Do not use)
if you have never had a vaginal yeast infection diagnosed by a doctor
Ask A Doctor Or P (Ask a doctor or p)
taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur.
Keep Out of Reach Of (Keep out of reach of)
If swallowed, get medical help or contact a Poison Control Center right away.
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
MONISTAT
®
3
COMBINATION PACK
Miconazole Nitrate Vaginal Inserts (200 mg) and
Miconazole Nitrate Vaginal Cream (2%) – Vaginal Antifungal
3 OVULE® Inserts Net Wt. 2.5 g each
+ 0.32 oz (9 g) Tube
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
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)
ask a health professional before use.
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, v omiting, 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
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Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:48.905973 · Updated: 2026-03-14T23:09:49.100948