Miconazole 3 Combination Pack

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Vaginal antifungal 

Vaginal antifungal

Uses

INDICATIONS & USAGE SECTION

• treats vaginal yeast infections
• relieves external itching and irritation due to a vaginal yeast infection

Warnings

WARNINGS SECTION

For vaginal use only

Do not use

OTC - DO NOT USE SECTION

if you have never had a vaginal yeast infection diagnosed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

When using this product

OTC - WHEN USING SECTION

• 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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. Wash 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
  

Other information

STORAGE AND HANDLING SECTION

• 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 (68º - 77ºF) [see USP controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Monistat® 3*

miconazole nitrate

Miconazole nitrate vaginal antifungal cream, USP 2%

and Miconazole nitrate vaginal suppositories, USP 200 mg

vaginal antifungal

combination pack

3 day treatment

• Cures most vaginal yeast infections
• Relieves associated external itching and irritation

net wt. oz (g) tube

+ 3 suppositories with 3 disposable applicators

*This product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat® 3.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product Linked Resources#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

• Miconazole 3 Combination Pack
• Miconazole Nitrate
• Miconazole 7
• MICONAZOLE
• BENZOIC ACID
• BUTYLATED HYDROXYANISOLE
• MINERAL OIL
• APRICOT KERNEL OIL PEG-6 ESTERS
• PEGOXOL 7 STEARATE
• WATER
• Miconazole 3
• HYDROGENATED PALM KERNEL OIL

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

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Product history page 1 of 2 · 43 observed states.

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Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

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