ADVERSE REACTIONS SECTION.

Adverse Reactions. Occasional cases of local stinging and burning have been reported.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

Carcinogenesis. No long-term studies in animals have been performed to evaluate carcinogenic potential.

CLINICAL PHARMACOLOGY SECTION.

Clinical Pharmacology. Fem pH acts to restore and maintain normal vaginal acidity through its buffered action.

CONTRAINDICATIONS SECTION.

Contraindications. None known.

DESCRIPTION SECTION.

Description. Fem pH Vaginal Jelly is bland, non-irritating water dispersible, buffered acid jelly for intravaginal use. Fem pH is classified as Vaginal Therapeutic Jelly. Fem pH contains 0.9% glacial acetic acid (C2H402) and 0.025% oxyquinoline sulfate (C18H16N206S) compounded with glycerin, lactic acid, poly ethylene glycol 4500 and purified water. Fem pH is formulated to pH 3.8-4.3 and is adjusted using N potassium hydroxide.

DOSAGE & ADMINISTRATION SECTION.

Dosage and Administration. The usual dose is one applicator full, administered intra-vaginally, morning and evening. Duration of treatment may be determined by the patients response to therapy. Each tube has tamper evident seal at the opening of the tube. Replace cap after each use. To fill applicator screw applicator clockwise onto the tube. Squeeze tube forcing Fem pH jelly into barrel until it is full. Then unscrew applicator counter-clockwise to remove from tube. Lie on your back with knees drawn up. Hold filled applicator by the barrel and gently insert it into the vagina as far as it will comfortably go. Press plunger to empty the contents. Keep the plunger depressed and remove the applicator from vagina. After each use pull applicator apart and wash with warm soapy water, rinse well, dry and reassemble.

DRUG INTERACTIONS SECTION.

Drug Interactions. No incidence of drug interactions has been reported with concomitant use of Fem pH and any other medication.

GENERAL PRECAUTIONS SECTION.

General. No special care is required for the safe and effective use of Fem pH.

HOW SUPPLIED SECTION.

How Supplied. 50g Tube (NDC 00813-0799-55) with Fem pH applicator. Keep this and all medication out of the reach of children. In case of accidental overdose, call doctor or poison control center immediately.Store at controlled room temperature 59-86F (15-30C).

INDICATIONS & USAGE SECTION.

Indications and Usage. Fem pH is indicated as adjunctive therapy in those cases where restoration and maintenance of vaginal acidity is desirable.

INSTRUCTIONS FOR USE SECTION.

Therapeutic Vaginal Jelly. Directions for using Fem pH applicator.Each tube has tamper evident seal at the opening of the tube. Replace cap after each use.To fill applicator screw applicator clockwise onto the tube. Squeeze tube forcing Fem pH jelly into barrel until it is full. Then unscrew applicator counter-clockwise to remove from tube. Lie on your back with knees drawn up. Hold filled applicator by the barrel and gently insert it into the vagina as far as it will comfortably go. Press plunger to empty the contents. Keep the plunger depressed and remove the applicator from vagina.After each use pull applicator apart and wash with warm soapy water, rinse well, dry and reassemble.. Figure. Figure. Figure.

LABORATORY TESTS SECTION.

Laboratory Tests. The monitoring of vaginal acidity (pH) may be helpful in following the patients response. (The normal vaginal pH has been shown to be in the range of 4.0 to 5.0).

NURSING MOTHERS SECTION.

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 Fem pH is administered to nursing woman.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 50g Tube Box. NDC 00813-0799-55Rx OnlyFem pH(TM) Therapeutic Vaginal Jelly Net Weight 50g (1.66 oz.) pharmicsINC. label.

PRECAUTIONS SECTION.

Precautions. General. No special care is required for the safe and effective use of Fem pH. Drug Interactions. No incidence of drug interactions has been reported with concomitant use of Fem pH and any other medication. Laboratory Tests. The monitoring of vaginal acidity (pH) may be helpful in following the patients 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 Fem pH. It is not known whether Fem pH can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Fem pH should be given to 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 Fem pH is administered to nursing woman.

PREGNANCY SECTION.

Pregnancy. Pregnancy Category C. Animal reproduction studies have not been conducted with Fem pH. It is not known whether Fem pH can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Fem pH should be given to pregnant woman only if clearly needed.

STORAGE AND HANDLING SECTION.

Keep this and all medication out of the reach of children. In case of accidental overdose, call doctor or poison control center immediately.Store at controlled room temperature 59-86F (15-30C).

WARNINGS SECTION.

Warnings. No serious adverse reactions or potential safety hazard have been reported with the use of Fem pH.