Acid Jelly Prescribing Information

Acid Jelly is a bland, non-irritating, water-dispersible, buffered acid jelly for intravaginal use. Acid Jelly is classified as a Vaginal Therapeutic Jelly. Acid Jelly contains 0.921% glacial acetic acid (C₂H₄O₂). Other ingredients include 0.7% ricinoleic acid (C₁₈H₃₄O₃), 0.025% oxyquinoline sulfate (C₁₈H₁₆N₂O₆S), 5% glycerin (C₃H₈O₃) compounded with tragacanth, acacia, propylparaben, potassium hydroxide, stannous chloride, egg albumen, potassium bitartrate, perfume and purified water. Acid Jelly is formulated to pH 3.9-4.1.

Clinical Pharacology

Acid Jelly acts to restore and maintain normal vaginal acidity through its buffer action.

Indications and Usage

Acid Jelly is indicated as adjunctive therapy in those cases where restoration and maintenance of vaginal acidity is desirable.

Contraindications

None known.

Warnings

No serious adverse reactions or potential safety hazards have been reported with the use of Acid Jelly.

Precautions

General: No special care is required for the safe and effective use of Acid Jelly. Drug Interactions: No incidence of drug interactions have been reported with concomitant use of Acid 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 3.8 to 4.2) 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 Acid Jelly. It is also not known whether Acid Jelly can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Acid 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 Acid Jelly is administered to a nursing woman.

Adverse Reactions

Occasional cases of local stinging and burning have been reported.

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

85 g tube (NDC 60267-125-85) with vaginal applicator.

NOTE: Store at controlled room temperature 15(-30( C (59(-86( F).

Rx Only.