April 30, 2017
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(butoconazole nitrate) Vaginal Cream USP, 2%


GYNAZOLE • 1® Butoconazole Nitrate Vaginal Cream USP, 2% contains butoconazole nitrate 2%, an Imidazole derivative with antlfungal activity. Its chemical name Is (±)-1-[4-(p-chlorophenyl)-2- [(2,6-dlchlorophenyl) thlo]butyi] Imidazole mononitrate, and It has the following chemical structure:

Gynazole (butoconazole nitrate) - Structural Formula Illustration

Butoconazole nitrate is a white to off-white crystalline powder with a molecular weight of 474.79. It Is sparingly soluble in methanol; slightly soluble In chloroform, methylene chloride, acetone, and ethanol; very slightly soluble In ethyl acetate; and practically insoluble In water. It melts at about 159°C with decomposition.

GYNAZOLE •1® Butoconazole Nitrate Vaginal Cream USP, 2% contains 2% butoconazole nitrate In a cream of edetate disodium, glyceryl monoisostearate, methylparaben, mineral oil, polyglyceryl-3 oleate, propylene glycol, propylparaben, colloidal silicon dioxide, sorbitol solution, purified water, and microcrystalline wax.

What are the possible side effects of butoconazole vaginal (Gynazole 1)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Other less serious side effects are more likely to occur, such as:

  • burning;
  • itching;
  • pelvic pain or cramps;
  • itching;
  • soreness and swelling; or
  • increased urination.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at...

Read All Potential Side Effects and See Pictures of Gynazole »

What are the precautions when taking butoconazole (Gynazole)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungal agents (such as clotrimazole, fluconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, immune system problems (such as HIV-AIDS), frequent vaginal yeast infections (more than 4 per year).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Ask your doctor whether you can have sexual intercourse while using...

Read All Potential Precautions of Gynazole »

Last reviewed on RxList: 7/12/2016
This monograph has been modified to include the generic and brand name in many instances.

Gynazole - User Reviews

Gynazole User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Gynazole sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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