TOPCARE  MICONAZOLE 3 YEAST INFECTION RELIEF- miconazole nitrate cream 
Topco Associates LLC

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TopCare®
Miconazole 3 Yeast Infection Relief

Drug Facts

Active ingredient (in each applicator)

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

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 1-888-423-0139

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 25 g Tube Carton

TopCare®

NDC 36800-070-09

3-DAY TREATMENT

Miconazole 3
MICONAZOLE NITRATE VAGINAL CREAM USP (4%)
VAGINAL ANTIFUNGAL
(MICONAZOLE NITRATE 200 mg PER APPLICATOR)

QUALITY
GUARANTEED

COMPARE TO
MONISTAT® 3
active ingredient*

One 0.9 oz (25 g) tube of three-day vaginal cream
with three disposable applicators

NET WT 0.9 OZ (25 g) TUBE
Consumer information leaflet enclosed

Principal Display Panel - 25 g Tube Carton
TOPCARE   MICONAZOLE 3 YEAST INFECTION RELIEF
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:36800-070
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (Miconazole) Miconazole Nitrate40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
cetyl alcohol 
isopropyl myristate 
polysorbate 60 
polysorbate 80 
potassium hydroxide 
propylene glycol 
water 
sorbitan monostearate 
stearyl alcohol 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-070-091 in 1 CARTON
125 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07677303/02/2005
Labeler - Topco Associates LLC (006935977)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(36800-070)

Revised: 1/2013
Document Id: fb2be2e9-360f-4142-8043-d95039ce6e9d
Set id: d6f3e419-45f2-4acc-9c14-daead374aa72
Version: 1
Effective Time: 20130110
 
Topco Associates LLC