NDC | 63736-413-01 |
Set ID | 587e42b4-cbdc-4a03-afae-f9e5e6605937 |
Category | HUMAN OTC DRUG LABEL |
Packager | Insight Pharmaceuticals LLC |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | ANDA075915 |
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each applicator)
- Purpose
- Uses
-
Warnings
For vaginal use only
Ask a doctor before use if you have
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vaginal itching and discomfort for the first time
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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
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
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vaginal itching and discomfort for the first time
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Directions
- 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 purple cap
○ insert entire content of applicator into the vagina at bedtime. Throw applicator away after use. - children under 12 years of age: ask a doctor.
- before using this product read the enclosed brochure and instructions on foil packet for complete directions and information
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Other information
- this product is a 1-dose treatment. Most women do not get complete relief of their symptoms in just one day. Most women get some improvement in 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
- this product is a 1-dose treatment. Most women do not get complete relief of their symptoms in just one day. Most women get some improvement in one day and complete relief of symptoms within 7 days.
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MONISTAT TIOCONAZOLE 1
tioconazole ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-413 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TIOCONAZOLE (UNII: S57Y5X1117) (TIOCONAZOLE - UNII:S57Y5X1117) TIOCONAZOLE 6.5 g in 100 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:63736-413-01 1 in 1 CARTON 11/21/2001 1 4.6 g in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075915 11/21/2001 Labeler - Insight Pharmaceuticals LLC (055665422)