MICONAZOLE 7- miconazole nitrate suppository 
Strategic Sourcing Services LLC

----------

Miconazole Nitrate Vaginal Suppositories, USP

Drug Facts

Active ingredient (in each vaginal suppository)

Miconazole nitrate, USP 100 mg

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
  • vaginal yeast infections often (such as once a month or 3 in 6 months). You may have a more serious condition. You could be pregnant or have a medical condition, such as diabetes or a weakened immune system.
  • lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
  • been exposed to the human immunodeficiency virus (HIV) that causes AIDS

Ask a doctor or pharmacist before use if you are

taking a prescription blood thinning medicine, such as warfarin, because bleeding or bruising may occur

When using this product

  • do not use tampons, douches, spermicides or other vaginal products
  • do not use condoms or diaphragms. They may be damaged by this product and not prevent pregnancy or sexually transmitted diseases (STDs).
  • do not have vaginal intercourse (sex)
  • mild increase in vaginal burning, itching or irritation may occur

Stop use and ask a doctor if

  • side effects occur.
  • 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 (1-800-222-1222) right away.

Directions

Other information

Inactive ingredient

hydrogenated vegetable oil

Questions?

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

Principal display panel

COMPARETO MONISTAT® 7 ACTIVE INGREDIENT*

miconazole 7

Vaginal Suppositories

Miconazole Nitrate Vaginal

Suppositories, USP 100 mg

Vaginal antifungal

Cures most vaginal yeast infections

7 VAGINAL SUPPOSITORIES WITH 1 REUSABLE PLASTIC APPLICATOR

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

Distributed by McKesson Corp.,

via Strategic Sourcing Services LLC,

Memphis, TN 38141

www.sunmarkbrand.com

Package label

Miconazole nitrate, USP 100 mg

SUNMARK Vaginal Suppositories

MICONAZOLE 7 
miconazole nitrate suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-833
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE100 mg
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
PALM KERNEL OIL (UNII: B0S90M0233)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-833-617 in 1 APPLICATOR; Type 0: Not a Combination Product12/09/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07350712/09/2011
Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 2/2022
Document Id: 6e7caa6d-bb98-4586-8a0b-998afb5744da
Set id: 89132802-beb1-42f4-8da4-39918fc5c4dd
Version: 11
Effective Time: 20220201
 
Strategic Sourcing Services LLC