MICONAZOLE 3 COMBINATION PACK- miconazole nitrate 
P & L Development, LLC

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Miconazole 3 Combination Pack

Drug Facts

Active ingredients

Miconazole nitrate, USP 200 mg (in each suppository)
Miconazole nitrate, USP 2% (external cream)

Purpose

Vaginal antifungal 

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

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 (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

Questions?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Monistat® 3*

miconazole nitrate

Miconazole nitrate vaginal antifungal cream, USP 2%

and Miconazole nitrate vaginal suppositories, USP 200 mg

vaginal antifungal

combination pack

3 day treatment

net wt. oz (g) tube

+ 3 suppositories with 3 disposable applicators

*This product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat® 3.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

Package Label

Miconazole nitrate, USP 200 mg (in each suppository Miconazole nitrate, USP 2% (external cream)

READYinCASE Miconazole Nitrate Combination

MICONAZOLE 3 COMBINATION PACK 
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-989
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-989-031 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product06/25/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 9 g
Part 21 BLISTER PACK
Part 1 of 2
MICONAZOLE 7 
miconazole nitrate cream
Product Information
Item Code (Source)NDC:59726-988
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)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
MINERAL OIL (UNII: T5L8T28FGP)  
APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ)  
PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
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
ANDAANDA07416405/01/2020
Part 2 of 2
MICONAZOLE 3 
miconazole nitrate suppository
Product Information
Item Code (Source)NDC:59726-987
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE200 mg
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
13 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07492606/25/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07492606/25/2021
Labeler - P & L Development, LLC (800014821)

Revised: 4/2023
Document Id: d9017236-cc5c-4959-91f8-8d0d1b36db60
Set id: a61ee45f-d2e0-4ac1-871d-fa1b3096e89b
Version: 4
Effective Time: 20230420
 
P & L Development, LLC