VAGISTAT-1- tioconazole ointment 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC


Drug Facts

Active ingredient (in each applicator)

Tioconazole 300 mg (6.5%)


Vaginal antifungal


treats vaginal yeast infections


For vaginal use only

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

[Enter Do Not Use here]

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
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 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.

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.


before using this product, read the enclosed brochure and instructions on foil packet for complete directions and information
adults and children 12 years of age and over:
open the foil packet just before use and remove blue cap
insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use.
children under 12 years of age: ask a doctor

Other information

this product is a 1-dose treatment. Most women do not experience complete relief of their symptoms in just one day. Most women experience some relief within one day and complete relief of symptoms within 7 days.
if you have questions about vaginal yeast infections, consult your doctor
store at 15° - 30°C (59° - 86°F)
see end flap of carton for lot number and expiration date

Inactive ingredients

butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum

Questions or comments?


Principal Display Panel

Vagistat-1 Carton
tioconazole ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-2090
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tioconazole (UNII: S57Y5X1117) (Tioconazole - UNII:S57Y5X1117) Tioconazole300 mg
Inactive Ingredients
Ingredient NameStrength
butylated hydroxyanisole (UNII: REK4960K2U)  
magnesium aluminum silicate (UNII: 6M3P64V0NC)  
petrolatum (UNII: 4T6H12BN9U)  
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-2090-461 in 1 CARTON; Type 0: Not a Combination Product02/11/199710/15/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 12/2016
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC