Miconazole Nitrate Vaginal Cream, Usp
facc7b65-0376-445a-8a3d-5180f2f9d5ff
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Miconazole nitrate, USP 2% (100 mg in each applicator)
Purpose
Vaginal antifungal
Medication Information
Purpose
Vaginal antifungal
Description
Miconazole nitrate, USP 2% (100 mg in each applicator)
Uses
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
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
Do Not Use
if you have never had a vaginal yeast infection diagnosed by a doctor
Questions?
Call 1-877-753-3935 Monday–Friday 9AM-5PM EST
Package Label
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 temperate 20° to 25°C (68° to 77°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
Principal Display Panel
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. oz (g) tube
7 day vaginal cream (1 tube)
+ 1 reusable applicator
*this product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat®.
Distributed by:
PL Developments
200 Hicks Street
Westbury, NY 11590
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
If Pregnant Or Breast Feeding,
ask a health professional before use.
Keep Out of Reach of Children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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
Ask A Doctor Or Pharmacist Before Use If You Are
taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur
Structured Label Content
Uses
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
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
Do Not Use (Do not use)
if you have never had a vaginal yeast infection diagnosed by a doctor
Questions?
Call 1-877-753-3935 Monday–Friday 9AM-5PM EST
Package Label (Package label)
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 temperate 20° to 25°C (68° to 77°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
Principal Display Panel (Principal display panel)
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. oz (g) tube
7 day vaginal cream (1 tube)
+ 1 reusable applicator
*this product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat®.
Distributed by:
PL Developments
200 Hicks Street
Westbury, NY 11590
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
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)
ask a health professional before use.
Keep Out of Reach of Children. (Keep out of reach of children.)
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur
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Source: dailymed · Ingested: 2026-02-15T12:04:14.365664 · Updated: 2026-03-14T23:04:49.494867