Monistat 7 Combination Pack
Monistat 7 Cure Itch Relief - PreFilledApps-Cream
9b1ac735-9b18-48c2-86dc-93d07157d5e5
HUMAN OTC DRUG LABEL
Aug 22, 2025
Insight Pharmaceuticals LLC
DUNS: 055665422
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Miconazole Nitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - Kit Carton
7- DAY****
TREATMENT
NEW LOOK!
MONISTAT®** 7**
Miconazole Nitrate Vaginal Cream (2%) – Vaginal Antifungal
COMBINATION PACK
7- DAY
TREATMENT
CREAM
Cream with 7 Disposable Applicators plus External Cream for Itch Relief
Net Wt. 1.59 oz (45 g) Tube + 0.32 oz (9 g) Tube
+ 7 Disposable Applicators
INDICATIONS & USAGE SECTION
Uses
-
treats vaginal yeast infections
-
relieves external itching and irritation due to a vaginal yeast infection
OTC - QUESTIONS SECTION
Questions?
**If you have any questions or comments, please call 1-****877-666-**4782
INACTIVE INGREDIENT SECTION
Inactive ingredients
benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol
SPL UNCLASSIFIED SECTION
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Miconazole nitrate 2%
Miconazole nitrate 2% (external cream)
OTC - PURPOSE SECTION
Purpose
Vaginal antifungal
Vaginal antifungal
WARNINGS SECTION
Warnings
For vaginal use only
Do not use
if you have never had a vaginal yeast infection diagnosed by a doctor**.**
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 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
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 disease (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 betterin***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 right away.
DOSAGE & ADMINISTRATION SECTION
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:
**▪****applicators:**insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw away applicator 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
OTHER SAFETY INFORMATION
Other information
-
do not use if****not use if seal over tube opening has been punctured
-
do not purchase if carton is open
-
store at 20° - 25°C (68° to 77°F)
-
Keep this carton for future refeence. It contains important information.