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NDC 63736-0413-01 MONISTAT TIOCONAZOLE 1 6.5 g/100g Details
MONISTAT TIOCONAZOLE 1 6.5 g/100g
MONISTAT TIOCONAZOLE 1 is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Insight Pharmaceuticals LLC. The primary component is TIOCONAZOLE.
Product Information
NDC | 63736-0413 |
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Product ID | 63736-413_c7b11d34-bd8a-4c84-aa4c-2cc6cf9037df |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | MONISTAT TIOCONAZOLE 1 |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | TIOCONAZOLE |
Product Type | HUMAN OTC DRUG |
Dosage Form | OINTMENT |
Route | TOPICAL |
Active Ingredient Strength | 6.5 |
Active Ingredient Units | g/100g |
Substance Name | TIOCONAZOLE |
Labeler Name | Insight Pharmaceuticals LLC |
Pharmaceutical Class | Azole Antifungal [EPC], Azoles [CS] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA075915 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 63736-0413-01 (63736041301)
NDC Package Code | 63736-413-01 |
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Billing NDC | 63736041301 |
Package | 1 APPLICATOR in 1 CARTON (63736-413-01) / 4.6 g in 1 APPLICATOR |
Marketing Start Date | 2001-11-21 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 587e42b4-cbdc-4a03-afae-f9e5e6605937 Details
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
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.
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
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
MONISTAT TIOCONAZOLE 1
tioconazole ointment |
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Labeler - Insight Pharmaceuticals LLC (055665422) |
Revised: 3/2019
Document Id: c7b11d34-bd8a-4c84-aa4c-2cc6cf9037df
Set id: 587e42b4-cbdc-4a03-afae-f9e5e6605937
Version: 1
Effective Time: 20190319