ACI-JEL Vaginal Jelly is a bland, non-irritating, water-dispersible, buffered acid jelly for intravaginal use. ACI-JEL is classified as a Vaginal Therapeutic Jelly. ACI-JEL contains 0.921% glacial acetic acid (C ₂ H ₄ O ₂ ), 0.025% oxyquinoline sulfate (C ₁₈ H ₁₆ N ₂ O ₆ S), 0.7% ricinoleic acid (C ₁₈ H ₃₄ O ₃ ), and 5% glycerin (C ₃ H ₈ O ₃ ) compounded with tragacanth, acacia, propylparaben, potassium hydroxide, stannous chloride, egg albumen, potassium bitartrate, perfume and purified water. ACI-JEL is formulated to pH 3.9-4.1.

Last updated on RxList: 12/8/2004

ACI-JEL is indicated as adjunctive therapy in those cases where restoration and maintenance of vaginal acidity is desirable.

The usual dose is one applicatorful, administered intravaginally, morning and evening. Duration of treatment may be determined by the patient's response to therapy.

85g Tube (NDC 0062-5421-01) with ORTHO® Measured-Dose Applicator.

Last updated on RxList: 12/8/2004

Occasional cases of local stinging and burning have been reported.

No incidence of drug interactions have been reported with concomitant use of ACI-JEL and any other medications. Laboratory Tests: The monitoring of vaginal acidity (pH) may be helpful in following the patient's response. (The normal vaginal pH has been shown to be in the range of 4.0 to 5.0.)

Last updated on RxList: 12/8/2004

No serious adverse reactions or potential safety hazards have been reported with the use of ACI-JEL.

General: No special care is required for the safe and effective use of ACI-JEL. Drug Interactions: No incidence of drug interactions have been reported with concomitant use of ACI-JEL and any other medications. Laboratory Tests: The monitoring of vaginal acidity (pH) may be helpful in following the patient's response. (The normal vaginal pH has been shown to be in the range of 4.0 to 5.0.) Carcinogenesis: No long-term studies in animals have been performed to evaluate carcinogenic potential. Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with ACI-JEL. It is also not known whether ACI-JEL can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ACI-JEL should be given to a pregnant woman only if clearly needed. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ACI-JEL is administered to a nursing woman.

Last updated on RxList: 12/8/2004

No Information Provided.

None known.

Last updated on RxList: 12/8/2004

ACI-JEL acts to restore and maintain normal vaginal acidity through its buffer action.

Last updated on RxList: 12/8/2004

No Information Provided.

Last updated on RxList: 12/8/2004

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

ACETIC ACID/OXYQUINOLINE/RICINOLEIC ACID - VAGINAL

(a-SEE-tik/OX-i-KWIN-oh-leen/rye-sin-oh-LAY-ick)

USES: This combination product is used to help restore and maintain the natural acid balance (pH) of the vagina, thereby treating vaginal infections (e.g., yeast, fungi) or making them less likely to occur. Acetic acid is commonly known as vinegar. Oxyquinoline and ricinoleic acid are substances added to help acetic acid work better. This product is thought to work by destroying or slowing the growth of organisms that cause vaginal infections.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

This medication is used only in the vagina, usually twice daily or as directed by your doctor. Do not take this medication by mouth. Wash your hands before and after each use. Fill the provided applicator with the medication as directed in the package information. Lie on your back with your knees drawn up and gently insert the applicator about 3/4 of an inch (2 centimeters) into the vagina. Press the plunger to release the drug. Keeping the plunger pressed down, remove the applicator from the vagina.

After each use, clean and rinse the applicator well with warm water.

Vaginal medicines will usually come out of the vagina during treatment. To keep the medicine from getting on your clothing, wear a sanitary napkin or panty liner pad. Do not use tampons because they may soak up the medicine and decrease its effect.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

If you are using this product to treat a vaginal infection, tell your doctor if your condition persists or worsens after a few days.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if this unlikely but serious side effect occurs: vaginal pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to acetic acid, oxyquinoline, or ricinoleic acid; or to eggs; or if you have any other allergies.

Before using this product, tell your doctor or pharmacist your medical history.

This product may decrease the effectiveness of certain birth control devices (e.g., latex condoms, diaphragms, vaginal rings, cervical caps) or make spermicides less effective. This can result in pregnancy. A different or additional method of birth control may be needed while using this product. Discuss with your doctor whether you should use other reliable methods of birth control.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this product, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: birth control devices (e.g., condoms, diaphragms), spermicides, vaginal products (e.g., douches, vaginal hormonal creams).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

This product is not a birth control method.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.