MONISTAT 3 COMBINATION PACK- miconazole nitrate 
Apex International Mfg., Inc.

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MONISTAT 3 Combination Pack - prefilled app and cream

DRUG FACTS

Active ingredients

Purpose

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

Miconazole nitrate 2% (external cream)       Vaginal antifungal

Uses

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

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

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

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

MONISTAT 3 COMBINATION PACK 
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57501-006
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57501-006-011 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product06/11/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 APPLICATOR 3 g
Part 21 TUBE 9 g
Part 1 of 2
MONISTAT 3 
miconazole nitrate cream
Product Information
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)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
15 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02067006/11/2020
Part 2 of 2
MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate10 mg  in 0.5 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
19 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02067006/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02067006/11/2020
Labeler - Apex International Mfg., Inc. (015226132)
Registrant - Apex International Mfg., Inc. (079110793)
Establishment
NameAddressID/FEIBusiness Operations
Apex International Mfg., Inc.079110793manufacture(57501-006)

Revised: 4/2020
Document Id: bde53bec-6b4a-4fdd-9499-9306b04ce4d2
Set id: 02c497e9-3b72-4dd2-83eb-a62b2eba1a9f
Version: 2
Effective Time: 20200423
 
Apex International Mfg., Inc.