TERAZOL 7- terconazole cream TERAZOL 3- terconazole cream TERAZOL 3- terconazole suppository

Terazol 3 by

Drug Labeling and Warnings

Terazol 3 by is a Prescription medication manufactured, distributed, or labeled by Janssen Pharmaceuticals, Inc., Janssen Cilag Manufacturing, LLC, Noramco, Inc., Janssen Ortho LLC, Janssen Pharmaceuticals, Inc, Jubilant HollisterStier General Partnership. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Janssen Ortho, LLC, Manati, Puerto Rico 00674 (for the Vaginal Cream)

    Jubilant HollisterStier General Partnership, Kirkland, Quebec, Canada H9H 4J4 (for the Vaginal Cream and Vaginal Suppositories)

    Manufactured for:

    (logo)

    Janssen Pharmaceuticals, Inc. Titusville, New Jersey 08560

    © Janssen Pharmaceuticals, Inc. 1998
    Revised May 2018

  • PATIENT PACKAGE INSERT

    TERAZOL® 7 VAGINAL CREAM 0.4%
    (terconazole)

    TERAZOL® 3 VAGINAL CREAM 0.8%
    (terconazole)

    PATIENT INSTRUCTIONS

    Filling the applicator:

    Using the applicator:

    Cleaning the applicator: (Does not apply to sample applicators, which are for one time use only)

    After each use, you should thoroughly clean the applicator by following the procedure below:

    NOTE: Store the cream at Controlled Room Temperature 15–30°C (59–86°F). See end flap for lot number and expiration date.

    TERAZOL® 3 VAGINAL SUPPOSITORIES 80 mg
    (terconazole)

    Three oval suppositories, for use inside the vagina only.

    Designed to be inserted into the vagina.

    HOW TO USE:

    Place one suppository into the vagina each night at bedtime, for 3 nights, as directed by your doctor. The TERAZOL® Suppository is self-lubricating and may be inserted with or without the applicator.

    NOTE: Store the suppositories at Controlled Room Temperature 15–30°C (59–86°F). See end flap for lot number and expiration date.

    A WORD ABOUT YEAST INFECTIONS

    Why do yeast infections occur?

    Yeast infections are caused by an organism called Candida (KAN di duh). It may be present in small and harmless amounts in the mouth, digestive tract, and vagina. Sometimes the natural balance of the vagina becomes upset. This may lead to rapid growth of Candida, which results in a yeast infection. Symptoms of a yeast infection include itching, burning, redness, and an abnormal discharge.

    Your doctor can make the diagnosis of a yeast infection by evaluating your symptoms and looking at a sample of the discharge under the microscope.

    How can I prevent yeast infections?

    Certain factors may increase your chance of developing a yeast infection. These factors don't actually cause the problem, but they may create a situation that allows the yeast to grow rapidly.

    Controlling these factors can help eliminate yeast infections and may prevent them from coming back.

    Some other helpful tips:

    Manufactured by:

    Manufactured for:

    (logo)

    Janssen Pharmaceuticals, Inc. Titusville, New Jersey 08560

    © Janssen Pharmaceuticals, Inc. 1998
    Revised July 2014

  • PRINCIPAL DISPLAY PANEL - 45g Tube Carton

    NDC: 50458-535-01

    TERAZOL® 7
    (terconazole)

    VAGINAL CREAM 0.4%
    Tube and Applicator

    Compounded with: Butylated hydroxyanisole, cetyl alcohol, isopropyl
    myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl
    alcohol and purified water.

    Rx only.

    Prescribing information enclosed. Store at controlled room temperature
    15-30°C (59-86°F). See end panel for lot number and expiration date.

    Keep out of reach of children.

    Net weight 1.59 oz. (45g)

    Manufactured by:
    Janssen Ortho, LLC
    Manati, Puerto Rico 00674

    Manufactured for:
    Janssen Pharmaceuticals, Inc.
    Titusville, NJ 08560

    janssen

    PRINCIPAL DISPLAY PANEL - 45g Tube Carton
  • PRINCIPAL DISPLAY PANEL - 20g Tube Carton

    NDC: 50458-536-01

    TERAZOL® 3
    (terconazole)

    VAGINAL CREAM 0.8%
    Tube and Applicator

    Compounded with: Butylated hydroxyanisole, cetyl alcohol, isopropyl
    myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl
    alcohol and purified water.

    Rx only.

    Prescribing information enclosed. Store at controlled room temperature
    15-30°C (59-86°F). See end panel for lot number and expiration date.

    Keep out of reach of children.

    Net weight 0.71 oz. (20g)

    Manufactured by:
    Janssen Ortho, LLC
    Manati, Puerto Rico 00674

    Manufactured for:
    Janssen Pharmaceuticals, Inc.
    Titusville, NJ 08560

    janssen

    PRINCIPAL DISPLAY PANEL - 20g Tube Carton
  • PRINCIPAL DISPLAY PANEL - 80mg Dose Pack Carton

    TERAZOL® 3
    (terconazole)

    VAGINAL SUPPOSITORIES 80mg
    With Applicator

    NDC: 0062-5351-01

    Each suppository contains terconazole 80 mg compounded with
    triglycerides derived from coconut and/or palm kernel oil (a base
    of hydrogenated vegetable oils) and butylated hydroxyanisole.

    Rx only.

    Prescribing information enclosed.
    Store at 15-30°C (59-86°F).
    See end panel for lot number and expiration date.
    Keep out of reach of children.

    3 suppositories with vaginal applicator.

    Manufactured by:
    DRAXIS Specialty Pharmaceuticals Inc.
    Kirkland, Quebec, Canada
    H9H 4J4

    ORTHO WOMEN'S HEALTH & UROLOGY
    DIVISION OF ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS, INC.

    Manufactured for:
    Ortho Women's Health & Urology,
    Division of Ortho-McNeil-Janssen
    Pharmaceuticals, Inc.
    Raritan, New Jersey 08869

    PRINCIPAL DISPLAY PANEL - 80mg Dose Pack Carton
  • INGREDIENTS AND APPEARANCE
    TERAZOL 7 
    terconazole cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 50458-535
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TERCONAZOLE (UNII: 0KJ2VE664U) (TERCONAZOLE - UNII:0KJ2VE664U) TERCONAZOLE4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITE (white to off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 50458-535-011 in 1 CARTON12/31/198706/30/2018
    145 g in 1 TUBE, WITH APPLICATOR; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01957912/31/1987
    TERAZOL 3 
    terconazole cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 50458-536
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TERCONAZOLE (UNII: 0KJ2VE664U) (TERCONAZOLE - UNII:0KJ2VE664U) TERCONAZOLE8 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITE (white to off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 50458-536-011 in 1 CARTON02/21/199110/31/2016
    120 g in 1 TUBE, WITH APPLICATOR; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01996402/21/199110/31/2016
    TERAZOL 3 
    terconazole suppository
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 50458-531
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TERCONAZOLE (UNII: 0KJ2VE664U) (TERCONAZOLE - UNII:0KJ2VE664U) TERCONAZOLE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    PALM KERNEL OIL (UNII: B0S90M0233)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    Product Characteristics
    ColorWHITE (white to off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 50458-531-011 in 1 CARTON05/24/198805/25/1988
    13 in 1 DOSE PACK; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01964105/24/198805/25/1988
    Labeler - Janssen Pharmaceuticals, Inc. (063137772)
    Establishment
    NameAddressID/FEIBusiness Operations
    Janssen Cilag Manufacturing, LLC963971374API MANUFACTURE(50458-535, 50458-536, 50458-531)
    Establishment
    NameAddressID/FEIBusiness Operations
    Noramco, Inc.057234486API MANUFACTURE(50458-535, 50458-536, 50458-531)
    Establishment
    NameAddressID/FEIBusiness Operations
    Janssen Ortho LLC084894661MANUFACTURE(50458-535, 50458-536, 50458-531)
    Establishment
    NameAddressID/FEIBusiness Operations
    Janssen Ortho LLC805887986ANALYSIS(50458-535, 50458-536, 50458-531)
    Establishment
    NameAddressID/FEIBusiness Operations
    Janssen Pharmaceuticals, Inc063137772ANALYSIS(50458-535, 50458-536, 50458-531)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jubilant HollisterStier General Partnership246762764ANALYSIS(50458-531) , MANUFACTURE(50458-531)

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