TERCONAZOLE by Dispensing Solutions, Inc. TERCONAZOLE cream

TERCONAZOLE by

Drug Labeling and Warnings

TERCONAZOLE by is a Prescription medication manufactured, distributed, or labeled by Dispensing Solutions, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Using the Applicator:

  • 1. Lie on your back with your knees drawn up toward your chest.
  • 2. Holding the applicator by the ribbed end of the barrel, insert the filled applicator into the vagina as far as it will comfortably go.
  • 3. Slowly press the plunger of the applicator to release the cream into the vagina.
  • Insert the fillled applicator into the vagina as far as it will comfortably go.
  • 4. Remove the applicator from the vagina.
  • 5. Apply one applicatorful each night for as many days at bedtime, as directed by your doctor.
  • Cleaning the Applicator:

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

  • 1. Pull the plunger out of the barrel.
    Pull the plunger out of the barrel.
  • 2. Wash the pieces with lukewarm, soapy water, and dry them thoroughly.
  • 3. Put the applicator back together by gently pushing the plunger into the barrel as far as it will go.
  • NOTE: Store the cream 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.

    • Clothing: Tight jeans, nylon underwear, pantyhose, and wet bathing suits can hold in heat and moisture (two conditions in which yeast organisms thrive). Looser pants or skirts, 100% cotton underwear, and stockings may help avoid this problem.
    • Diet: Cutting down on sweets, milk products, and artificial sweeteners may reduce the risk of yeast infections.
    • Antibiotics: Antibiotics work by eliminating disease-causing organisms. While they are helpful in curing other problems, antibiotics may lead to an overgrowth of Candida in the vagina.
    • Pregnancy: Hormonal changes in the body during pregnancy encourage the growth of yeast. This is a very common time for an infection to occur. Until the baby is born, it may be hard to completely eliminate yeast infections. If you believe you are pregnant, tell your doctor.
    • Menstruation: Sometimes monthly changes in hormone levels may lead to yeast infections.
    • Diabetes: In addition to heat and moisture, yeast thrives on sugar. Because diabetics often have sugar in their urine, their vaginas are rich in this substance. Careful control of diabetes may help prevent yeast infection.

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

    Some Other Helpful Tips:

  • 1. For best results, be sure to use the medication as prescribed by your doctor, even if you feel better quickly.
  • 2. Avoid sexual intercourse, if your doctor advises you to do so.
  • 3. If your partner has any penile itching, redness, or discomfort, he should consult his physician and mention that you are being treated for a yeast infection.
  • 4. You can use the medication even if you are having your menstrual period. However, you should not use tampons because they may absorb the medication. Instead, use external pads or napkins until you have finished your medication. You may also wish to wear a sanitary napkin if the vaginal medication leaks.
  • 5. Dry the genital area thoroughly after showering, bathing, or swimming. Change out of a wet bathing suit or damp exercise clothes as soon as possible. A dry environment is less likely to encourage the growth of yeast.
  • 6. Wipe from front to rear (away from the vagina) after a bowel movement.
  • 7. Don't douche unless your doctor specifically tells you to do so. Douching may disturb the vaginal balance.
  • 8. Don't scratch if you can help it. Scratching can cause more irritation and spread the infection.
  • 9. Discuss with your physician any medication you are already taking. Certain types of medication can make your vagina more susceptible to infection.
  • 10. Eat nutritious meals to promote your general health.
  • Mfd. for:

    Watson Laboratories, Inc.
    Corona, CA 92880 USA

    Mfd. by:

    Draxis Specialty Pharmaceuticals Inc.
    Kirkland, Quebec, Canada H9H 4J4
    or

     

    JOLLC
    Manati, Puerto Rico 00674

      
    Printed in U.S.A.Revised January 2010
  • PRINCIPAL DISPLAY PANEL

    NDC: <a href=/NDC/55045-3259-0>55045-3259-0</a>3

    NDC: 55045-3259-03

    PRINCIPAL DISPLAY PANEL

    Terconazole Vaginal Cream
    0.8%
    Tube and Applicator
    For Vaginal Use Only.

    Rx only

    Net Wt 0.71 oz. (20 g)
    Quantity by weight not by volume.

  • INGREDIENTS AND APPEARANCE
    TERCONAZOLE 
    terconazole cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 55045-3259(NDC: 0591-3197)
    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: 55045-3259-320 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01996404/01/2004
    Labeler - Dispensing Solutions, Inc. (066070785)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dispensing Solutions, Inc.066070785relabel, repack

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