Prescription Drugs

CLINICAL PHARMACOLOGY ACI-JEL (vaginal jelly) acts to restore and maintain normal vaginal acidity through its buffer action.

DESCRIPTION ACI-JEL Vaginal Jelly is a bland, non-irritating, water-dispersible, buffered acid jelly for intravaginal use. ACI-JEL (vaginal jelly) is classified as a Vaginal Therapeutic Jelly. ACI-JEL (vaginal jelly) 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 (vaginal jelly) is formulated to pH 3.9-4.1.

INDICATIONS ACI-JEL (vaginal jelly) is indicated as adjunctive therapy in those cases where restoration and maintenance of vaginal acidity is desirable. DOSAGE AND ADMINISTRATION The usual dose is one applicatorful, administered intravaginally, morning and evening. Duration of treatment may be determined by the patient's response to therapy. HOW SUPPLIED 85g Tube (NDC 0062-5421-01) with ORTHO® Measured-Dose Applicator.

PATIENT INFORMATION No Information Provided.

OVERDOSE No Information Provided. CONTRAINDICATIONS None known.

WARNINGS No serious adverse reactions or potential safety hazards have been reported with the use of ACI-JEL (vaginal jelly) . PRECAUTIONS General: No special care is required for the safe and effective use of ACI-JEL (vaginal jelly) . Drug Interactions: No incidence of drug interactions have been reported with concomitant use of ACI-JEL (vaginal jelly) 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 (vaginal jelly) . It is also not known whether ACI-JEL (vaginal jelly) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ACI-JEL (vaginal jelly) 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 (vaginal jelly) is administered to a nursing woman.