Miconazole Nitrate
f562b57d-65a8-93fa-e053-2995a90ae3e0
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:
- applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator 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
Questions?
call 1-866-923-4914
Active Ingredient
Miconazole nitrate USP 2% (100 mg in each applicatorful)
Other Information
- do not purchase if carton is opened
- do not use if seal over tube opening has been punctured or is not visible
- store at 20° to 25°C (68° to 77°F)
- see carton or tube crimp for lot number and expiration date
Inactive Ingredients
benzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and purified water.
Principal Display Panel
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
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:
- applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator 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
Questions?
call 1-866-923-4914
Active Ingredient (Active ingredient)
Miconazole nitrate USP 2% (100 mg in each applicatorful)
Other Information (Other information)
- do not purchase if carton is opened
- do not use if seal over tube opening has been punctured or is not visible
- store at 20° to 25°C (68° to 77°F)
- see carton or tube crimp for lot number and expiration date
Inactive Ingredients (Inactive ingredients)
benzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and purified water.
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
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
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:00:34.695085 · Updated: 2026-03-14T23:01:03.935839