Sunmark Tioconazole 1

Name: Sunmark Tioconazole 1

Purpose

Vaginal antifungal

Uses

  • treats vaginal yeast infections

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 human immunodeficiency virus (HIV) that causes AIDS

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 disease (STDs).
  • do not have vaginal intercourse
  • mild increase in vaginal burning, itching or irritation may occur

Stop use and ask a doctor if

  • 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 right away.

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to 1-Day™ active ingredient

1-Dose Treatment

Tioconazole-1

Tioconazole Ointment, 6.5%

Vaginal Antifungal

Cures Most Vaginal Yeast Infections

Educational Brochure Enclosed

# Convenient Prefilled Applicator

Tioconazole 1 Carton

Sunmark Tioconazole 1 
tioconazole ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-508
Route of Administration VAGINAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIOCONAZOLE (TIOCONAZOLE) TIOCONAZOLE 6.5 g  in 100 g
Product Characteristics
Color BROWN (light to dark tan) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:49348-508-59 1 APPLICATOR (APPLICATOR) in 1 CARTON
1 4.6 g in 1 APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075915 12/18/2007
Labeler - McKesson (177667227)
Revised: 11/2009   McKesson
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