Monistat 3 Combination Pack - Prefilled App And Cream

Monistat 3 Combination Pack - Prefilled App And Cream
SPL v2
SPL
SPL Set ID 02c497e9-3b72-4dd2-83eb-a62b2eba1a9f
Route
VAGINAL
Published
Effective Date 2020-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (40 mg)
Inactive Ingredients
Benzoic Acid Cetyl Alcohol Isopropyl Myristate Polysorbate 60 Potassium Hydroxide Propylene Glycol Water Stearyl Alcohol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
NDA Active Since 2020-06-11

Description

DRUG FACTS

Purpose

Miconazole nitrate 4% (200 mg in each applicator)       Vaginal antifungal Miconazole nitrate 2% (external cream)       Vaginal antifungal


Medication Information

Purpose

Miconazole nitrate 4% (200 mg in each applicator)       Vaginal antifungal

Miconazole nitrate 2% (external cream)       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 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 .

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
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:
    • applicators : insert 1 suppository into the vagina at bedtime for 3 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
Questions?

If you have any questions or comments, please call 1-877-666-4782

Other Information
  • do not use if printed suppository wrapper is torn, open or incompletely sealed

  • do not use if seal over tube opening has been punctured

  • do not purchase if carton is open

  • store at 20°-25°C (68°-77°F)
Inactive Ingredients

benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol

Principal Display Panel

Monistat®

C O M B I N A T I O N  P A C K



Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Vaginal Cream (2%)

(Miconazole Nitrate 200 mg per applicator plus 2% external vulvar cream)



VAGINAL ANTIFUNGAL



• CURES most vaginal YEAST INFECTIONS

• Relieves associated external itching and irritation



3 PREFILLED APPLICATORS

plus External Cream for Itch Relief



Net Wt. 0.18 oz (5g) each applicator

+ 0.32 oz (9g) Tube



3-DAY

TREATMENT

COMBINATION PACK




Prefilled Cream



3 Ready-to-Use Prefilled Applicators plus External Cream for Itch Relief



TAMPER-EVIDENT UNIT DO NOT

USE IF PRINTED APPLICATOR

WRAPPER IS TORN, OPEN OR

INCOMPLETELY SEALED.



If you have any

questions or

comments, please call

1-877-MONISTAT

(1-877-666-4782)



Dist. by Insight Pharmaceuticals LLC, Tarrytown, NY 10591

A Prestige Consumer Healthcare company

©2019 Trade dress is owned by Insight Pharmaceuticals LLC.

All rights reserved. MNUS013106



Monistat®

C O M B I N A T I O N  P A C K



Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Vaginal Cream (2%)

(Miconazole Nitrate 200 mg per applicator plus 2% external vulvar cream)



VAGINAL ANTIFUNGAL



• CURES most vaginal YEAST INFECTIONS

• Relieves associated external itching and irritation



3 PREFILLED APPLICATORS

plus External Cream for Itch Relief



Net Wt. 0.18 oz (5g) each applicator

+ 0.32 oz (9g) Tube



3-DAY

TREATMENT

COMBINATION PACK




Prefilled Cream



3 Ready-to-Use Prefilled Applicators plus External Cream for Itch Relief



TAMPER-EVIDENT UNIT DO NOT

USE IF PRINTED APPLICATOR

WRAPPER IS TORN, OPEN OR

INCOMPLETELY SEALED.



If you have any

questions or

comments, please call

1-877-MONISTAT

(1-877-666-4782)



Dist. by Insight Pharmaceuticals LLC, Tarrytown, NY 10591

A Prestige Consumer Healthcare company

©2019 Trade dress is owned by Insight Pharmaceuticals LLC.

All rights reserved. MNUS001107



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 right away.


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 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 .

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
Purpose

Miconazole nitrate 4% (200 mg in each applicator)       Vaginal antifungal

Miconazole nitrate 2% (external cream)       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:
    • applicators : insert 1 suppository into the vagina at bedtime for 3 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
Questions?

If you have any questions or comments, please call 1-877-666-4782

Other Information (Other information)
  • do not use if printed suppository wrapper is torn, open or incompletely sealed

  • do not use if seal over tube opening has been punctured

  • do not purchase if carton is open

  • store at 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Monistat®

C O M B I N A T I O N  P A C K



Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Vaginal Cream (2%)

(Miconazole Nitrate 200 mg per applicator plus 2% external vulvar cream)



VAGINAL ANTIFUNGAL



• CURES most vaginal YEAST INFECTIONS

• Relieves associated external itching and irritation



3 PREFILLED APPLICATORS

plus External Cream for Itch Relief



Net Wt. 0.18 oz (5g) each applicator

+ 0.32 oz (9g) Tube



3-DAY

TREATMENT

COMBINATION PACK




Prefilled Cream



3 Ready-to-Use Prefilled Applicators plus External Cream for Itch Relief



TAMPER-EVIDENT UNIT DO NOT

USE IF PRINTED APPLICATOR

WRAPPER IS TORN, OPEN OR

INCOMPLETELY SEALED.



If you have any

questions or

comments, please call

1-877-MONISTAT

(1-877-666-4782)



Dist. by Insight Pharmaceuticals LLC, Tarrytown, NY 10591

A Prestige Consumer Healthcare company

©2019 Trade dress is owned by Insight Pharmaceuticals LLC.

All rights reserved. MNUS013106



Monistat®

C O M B I N A T I O N  P A C K



Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Vaginal Cream (2%)

(Miconazole Nitrate 200 mg per applicator plus 2% external vulvar cream)



VAGINAL ANTIFUNGAL



• CURES most vaginal YEAST INFECTIONS

• Relieves associated external itching and irritation



3 PREFILLED APPLICATORS

plus External Cream for Itch Relief



Net Wt. 0.18 oz (5g) each applicator

+ 0.32 oz (9g) Tube



3-DAY

TREATMENT

COMBINATION PACK




Prefilled Cream



3 Ready-to-Use Prefilled Applicators plus External Cream for Itch Relief



TAMPER-EVIDENT UNIT DO NOT

USE IF PRINTED APPLICATOR

WRAPPER IS TORN, OPEN OR

INCOMPLETELY SEALED.



If you have any

questions or

comments, please call

1-877-MONISTAT

(1-877-666-4782)



Dist. by Insight Pharmaceuticals LLC, Tarrytown, NY 10591

A Prestige Consumer Healthcare company

©2019 Trade dress is owned by Insight Pharmaceuticals LLC.

All rights reserved. MNUS001107



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 right away.


Advanced Ingredient Data


Raw Label Data

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