Label: TIOCONAZOLE 1 DAY- tioconazole ointment
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated July 2, 2012
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each applicator)
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
- 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:
- open the foil packet just before use and remove purple 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
- 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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4.6g Applicator Carton
INGREDIENTS AND APPEARANCE
TIOCONAZOLE 1 DAY
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-410 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Tioconazole (UNII: S57Y5X1117) (Tioconazole - UNII:S57Y5X1117) Tioconazole 300 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:63736-410-01 1 in 1 CARTON 1 1 in 1 POUCH 1 4.6 g in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075915 11/21/2001 Labeler - Insight Pharmaceuticals LLC (176792315) Establishment Name Address ID/FEI Business Operations Perrigo 006013346 MANUFACTURE(63736-410)