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  5. Label Information: Fem Ph

FDA Label for Fem Ph

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. DESCRIPTION
    3. CLINICAL PHARMACOLOGY
    4. INDICATIONS AND USAGE
    5. CONTRAINDICATIONS
    6. WARNINGS
    7. GENERAL
    8. DRUG INTERACTIONS
    9. LABORATORY TESTS
    10. CARCINOGENESIS
    11. PREGNANCY CATEGORY C
    12. NURSING MOTHERS
    13. ADVERSE REACTIONS
    14. DOSAGE AND ADMINISTRATION
    15. HOW SUPPLIED
    16. STORAGE AND HANDLING
    17. THERAPEUTIC VAGINAL JELLY
    18. PRINCIPAL DISPLAY PANEL - 50G TUBE BOX

Fem Ph Product Label

The following document was submitted to the FDA by the labeler of this product Pharmics, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Rx Only

Mfg. by:
Pernix Manufacturing
Houston, TX 77099

Mfg. for:
Pharmics, Inc.
Salt Lake City, UT 84119
(801) 966-4138
www.pharmics.com

Revised 05/13


Description



Fem pH Vaginal Jelly is a bland, non-irritating water dispersible, buffered acid jelly for intravaginal use. Fem pH is classified as a 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 1 N potassium hydroxide.


Clinical Pharmacology



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


Indications And Usage



Fem pH 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 hazard have been reported with the use of Fem pH.


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 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 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 a pregnant woman or can affect reproduction capacity. Fem pH 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 Fem pH 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 applicator full, administered intra-vaginally, morning and evening. Duration of treatment may be determined by the patient's response to therapy. Each tube has a 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.


How Supplied



50g Tube (NDC 00813-0799-55) with Fem pH applicator.


Storage And Handling



Keep this and all medication out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Store at controlled room temperature 59°-86°F (15°-30°C)


Therapeutic Vaginal Jelly



Directions for using Fem pH applicator.

Figure - femph 01

Figure - femph 01

Each tube has a 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.


Principal Display Panel - 50G Tube Box



NDC 00813-0799-55

Rx Only

Fem pH™
Therapeutic Vaginal Jelly

Net Weight 50g
(1.66 oz.)

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