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.
ACI-JEL acts to restore and maintain normal vaginal acidity through its buffer action.
ACI-JEL is indicated as adjunctive therapy in those cases where restoration and maintenance of vaginal acidity is desirable.
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' 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.
Occasional cases of local stinging and burning have been reported.
The usual dose is one applicatorful, administered intravaginally, morning and evening. Duration of treatment may be determined by the patient' response to therapy.
85g Tube (NDC 0062-5421-01) with ORTHO® Measured-Dose Applicator.
Revised June 1998 643-10-310-3