FREDS  MICONAZOLE 3- miconazole nitrate cream 
FRED'S, INC.

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Fred's
Miconazole 3

Drug Facts

Active ingredient

Miconazole Nitrate USP 4% (200 mg in each applicatorful)

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
  • 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

cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, potassium hydroxide, propylene glycol, purified water, sorbitan monostearate and stearyl alcohol.

Questions?

Call 1-866-923-4914

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD,
MEMPHIS, TN 38118

PRINCIPAL DISPLAY PANEL - 25 g Tube Carton

fred's
Pharmacy

Cures Most Vaginal
Yeast Infections

3 Day
Treatment

MICONAZOLE
3
Miconazole Nitrate Vaginal Cream USP (4%)
(Miconazole Nitrate 200 mg per applicator)

VAGINAL ANTIFUNGAL

ONE 0.9 oz (25 g) TUBE OF 3 DAY VAGINAL CREAM WITH 3 DISPOSABLE APPLICATORS

Consumer
Information
Leaflet Enclosed

PRINCIPAL DISPLAY PANEL - 25 g Tube Carton
FREDS   MICONAZOLE 3
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-737
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
cetyl alcohol (UNII: 936JST6JCN)  
isopropyl myristate (UNII: 0RE8K4LNJS)  
polysorbate 60 (UNII: CAL22UVI4M)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
potassium hydroxide (UNII: WZH3C48M4T)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sorbitan monostearate (UNII: NVZ4I0H58X)  
stearyl alcohol (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-737-431 in 1 CARTON12/20/2018
125 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07677303/02/2005
Labeler - FRED'S, INC. (005866116)

Revised: 1/2019
Document Id: 4c5dc483-ffb4-4a86-bdd1-dbfef0d41a26
Set id: 35bd36ef-1bf5-480c-9a5b-7faf4c935476
Version: 1
Effective Time: 20190102
 
FRED'S, INC.