MICONAZOLE 7- miconazole nitrate cream 
Preferred Pharmaceuticals Inc.

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Miconazole 7

Drug Facts

Active ingredient

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

Purpose

Vaginal antifungal

Uses

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 (1-800-222-1222) 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:
applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use.
use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days as needed.
children under 12 years of age: ask a doctor

Other information

to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
do not use if foil seal on tube opening is broken or missing
do not purchase if carton is open
store at room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F)
before using any medication, read all label directions. Keep carton, it contains important 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

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117

Relabeled By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

NDC 68788-7917-4

*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

Cures most vaginal yeast infections
Relieves associated external itching and irritation

Net wt. 1.59 oz (45 g) Tube
7 day vaginal cream (1 tube) with 1 reusable applicator

H2pharma

Relabeled By: Preferred Pharmaceuticals Inc.

Miconazole Nitrate Vaginal Cream 2%
MICONAZOLE 7 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7917(NDC:61269-730)
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:68788-7917-41 in 1 CARTON05/27/2021
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
ANDAANDA07416405/27/2021
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-7917)

Revised: 8/2023
Document Id: df16c16f-8de0-4edc-9242-4e3eed2321ea
Set id: 99c66cbd-7063-4b4c-b827-4f2fcb6ed67f
Version: 3
Effective Time: 20230808
 
Preferred Pharmaceuticals Inc.