FDA Label for Monistat 3 Combination Pack

Purpose

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

Miconazole nitrate 2% (external cream)       Vaginal antifungal

Uses

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

Warnings

For vaginal use only

Otc - Do Not Use

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

Otc - Ask Doctor/Pharmacist

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 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.

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
  
  

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

Questions?

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

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

carton - carton

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