Label: TIOCONAZOLE OINTMENT 6.5%- tioconazole ointment
- NDC Code(s): 63094-0426-1
- Packager: DPT Laboratories, Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated August 31, 2009
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
(i n each applicator)
Tioconazole 300 mg (6.5%)
vaginal antifungal Close
- treats vaginal yeast infections
For vaginal use only
- DO NOT USE
Do not use if you have never had a vaginal yeast infection diagnosed by a doctor Close
- 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
- PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before use. Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Close
- before using this product read the enclosed brochure and instructions on foil packet for complete directions and information
- adults and children 12 years and over: 1.Open the foil packet just before use and remove purple cap. 2.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 20 - 25°C (68 - 77°F)
- see end flap of carton for lot number and expiration date
- Inactive ingredients
butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum Close
- INDICATIONS & USAGE
Do not use if sealed foil packet torn, open, or incompletely sealed.
TIOCONAZOLE OINTMENT 6.5%
DIRECTIONS FOR USE
- Tear open foil packet just before using. It is best to use at bedtime.
- Remove applicator and plunger from packet. Applicator is prefilled with vaginal ointment.
- While firmly holding the purple-capped end of the applicator, push the tip of the plunger into the base of applicator.
REMOVE PURPLE CAP from top of applicator with a pull-twist action.
Insert the applicator
- Lie on your back with your knees bent. Gently insert applicator into the vagina as far as it will go comfortably.
- Push the plunger into the applicator until it will go no farther. Withdraw the applicator and plunger and dispose of it in the wastebasket. Do not flush.
- DO NOT USE TAMPONS while using this medicine. Use sanitary napkins instead.
PLEASE READ EDUCATIONAL BROCHURE FOR ADDITIONAL INFORMATION.
ALLEGAN, MI 48010 U.S.A.
- INGREDIENTS AND APPEARANCE
TIOCONAZOLE OINTMENT 6.5%
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63094-0426 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TIOCONAZOLE (UNII: S57Y5X1117) (TIOCONAZOLE - UNII:S57Y5X1117) TIOCONAZOLE 65 mg in 1 g Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63094-0426-1 5 g in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075915 08/22/2007 Labeler - DPT Laboratories, Ltd. (621782218) Registrant - DPT Laboratories, Ltd. (621782218) Establishment Name Address ID/FEI Business Operations DPT Laboratories, Ltd. 621782218 manufacture