MICONAZOLE 7- miconazole nitrate cream 
P & L Development, LLC

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Miconazole Nitrate Vaginal Cream, USP

Drug Facts

Active ingredient

Miconazole nitrate, USP 2% (100 mg in each applicator)

Purpose

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

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

Stop use and ask a doctor if

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

benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

Questions?

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

Principal display panel

Compare to the active ingredient in Monistat® 7 Vaginal Cream*

miconazole 7

miconazole nitrate vaginal cream USP 2%

(miconazole nitrate 100 mg per applicator

vaginal antifungal

net wt. oz (g) tube

7 day vaginal cream (1 tube)

+ 1 reusable applicator

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

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

Package label

Miconazole nitrate USP, 2% (100 mg in each applicator

READYinCASE Vaginal Antifungal

MICONAZOLE 7 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-988
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 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
1NDC:59726-988-011 in 1 CARTON05/28/2021
145 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07416405/28/2021
Labeler - P & L Development, LLC (800014821)

Revised: 11/2022
Document Id: 222ad9fe-4c25-493e-8eea-98f554ef9c1f
Set id: facc7b65-0376-445a-8a3d-5180f2f9d5ff
Version: 2
Effective Time: 20221102
 
P & L Development, LLC