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MONISTAT 3 COMBINATION PACK(Miconazole Nitrate)
2017-09-03 06:37:14 来源: 作者: 【 】 浏览:520次 评论:0

SPL UNCLASSIFIED SECTION

Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Vaginal Cream
(2%)
Vaginal Antifungal

DRUG FACTS

ACTIVE INGREDIENT

Active ingredients Purpose
Miconazole nitrate (200 mg in each suppository) Vaginal antifungal
Miconazole nitrate 2% (external cream) Vaginal antifungal

Us

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

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 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

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:
  • suppositories: 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 blister is torn, open or incompletely sealed
  • do not use if seal over tube opening has been punctured or embossed design embossed design is not visible

  • do not purchase if carton is open
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

suppository: hydrogenated vegetable oil base

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

QUESTIONS

Questions? If you have any questions or comments, please call 1-877-666-4782
Visit our website @ www.monistat.com

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - Kit Carton

3 DAY TREATMENT • CREAM

MONISTAT® 3
Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Cream (2%)
(Miconazole Nitrate 200 mg per applicator plus 2% external vulvar cream)
VAGINAL ANTIFUNGAL

CLINICALLY PROVEN
MULTI-SYMPTOM RELIEF

CURES MOST VAGINAL YEAST INFECTIONS
and relieves associated external itching and irritation

COMBINATION PACK

Net Wt. 0.18 oz. (5g) each applicator • 0.32 oz. (9g) tube

Principal Display Panel

INGREDIENTS AND APPEARANCE

 

MONISTAT 3 COMBINATION PACK  miconazole nitrate kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-018
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63736-018-03 1 in 1 PACKAGE, COMBINATION    
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BLISTER PACK
Part 2 1 TUBE 9 g
Part 1 of 2
MONISTAT 3  miconazole nitrate suppository
Product Information
Route of Administration VAGINAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate 200 mg
Inactive Ingredients
Ingredient Name Strength
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
 
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1   3 in 1 BLISTER PACK    
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020670 12/10/2009  
Part 2 of 2
MICONAZOLE NITRATE  miconazole nitrate cream
Product Information
Route of Administration VAGINAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate 10 mg  in 0.5 g
Inactive Ingredients
Ingredient Name Strength
Benzoic Acid (UNII: 8SKN0B0MIM)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Potassium Hydroxide (UNII: WZH3C48M4T)  
Propylene glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Stearyl Alcohol (UNII: 2KR89I4H1Y)  
 
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1   9 g in 1 TUBE    
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020670 12/10/2009  
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020670 12/10/2009  
Labeler - Insight Pharmaceuticals (176792315)
Establishment
Name Address ID/FEI Business Operations
Jubilant   246762764 MANUFACTURE(63736-018)
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