Miconazole 3 Combination Pack

Miconazole 3 Combination Pack
SPL v5
SPL
SPL Set ID a61ee45f-d2e0-4ac1-871d-fa1b3096e89b
Route
VAGINAL
Published
Effective Date 2024-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (10 mg)
Inactive Ingredients
Benzoic Acid Butylated Hydroxyanisole Mineral Oil Apricot Kernel Oil Peg-6 Esters Pegoxol 7 Stearate Water Hydrogenated Palm Kernel Oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2021-06-25

Description

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

Purpose

Vaginal antifungal  Vaginal antifungal


Medication Information

Purpose

Vaginal antifungal 

Vaginal antifungal

Description

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

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:
    • 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

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
READYinCASE Miconazole Nitrate Combination
Other Information
  • 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)
Active Ingredients

Miconazole nitrate, USP 200 mg (in each suppository)

Miconazole nitrate, USP 2% (external cream)

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

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
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 

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:
    • 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

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
READYinCASE Miconazole Nitrate Combination
Other Information (Other information)
  • 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)
Active Ingredients (Active ingredients)

Miconazole nitrate, USP 200 mg (in each suppository)

Miconazole nitrate, USP 2% (external cream)

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

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
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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