MONISTAT 3 3 DAY- miconazole nitrate cream 
Insight Pharmaceuticals LLC

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Monistat 3 3 Day 63736-015

Drug Facts

Active ingredient

Miconazole nitrate 4%

Purpose

Vaginal antifungal

Use

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 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 disease (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 after 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

Other information

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 

Drug Facts

Active ingredient

Miconazole nitrate 4%

Purpose

Vaginal antifungal

Use

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 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 disease (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 after 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

Other information

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 - 5 g Tube Carton

3-DAY TREATMENT

Prefilled Cream Applicator

MONISTAT® 3
Miconazole Nitrate Vaginal Cream (4%)- Vaginal Antifungal

3 Prefilled Applicators Net Wt. 0.18 oz. (5g) each

3-DAY TREATMENT
Prefilled Cream Applicator
MONISTAT® 3
Miconazole Nitrate Vaginal Cream (4%)- Vaginal Antifungal
3 Prefilled Applicators Net Wt. 0.18 oz. (5g) each applicator

PRINCIPAL DISPLAY PANEL

3 DAY TREATMENT • CREAM

MONISTAT® 3
Miconazole Nitrate Vaginal Cream (4%)
Vaginal Antifungal

Net Wt. 0.9 oz. (25g) Tube + 1 Reusable Applicator

PRINCIPAL DISPLAY PANEL 
3 DAY TREATMENT • CREAM
MONISTAT® 3
Miconazole Nitrate Vaginal Cream (4%)
Vaginal Antifungal
Net Wt. 0.9 oz. (25g) Tube + 1 Reusable Applicator

PRINCIPAL DISPLAY PANEL 
3 DAY TREATMENT • CREAM
MONISTAT® 3
Miconazole Nitrate Vaginal Cream (4%)
Vaginal Antifungal
Net Wt. 0.9 oz. (25g) Tube + 1 Reusable Applicator

MONISTAT 3  3 DAY
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-015
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-015-183 in 1 CARTON03/30/1998
15 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
2NDC:63736-015-251 in 1 CARTON03/30/1998
225 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02082703/30/1998
Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 8/2023
Document Id: 9202303b-e2d0-4d9a-afb3-93f2a8396f56
Set id: f38c7e1d-2439-4b3b-8be8-60b2d8e61ce5
Version: 5
Effective Time: 20230830
 
Insight Pharmaceuticals LLC