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Fem pH (Pharmics, Inc.)

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JELLY 50 g in 1 TUBE (0813-0799-55) Label Information

Complete Fem pH Information

  • SPL UNCLASSIFIED SECTION

    Rx Only


  • 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.


  • 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 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 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.

    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)


  • SPL UNCLASSIFIED SECTION

    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


  • Therapeutic Vaginal Jelly

    Directions for using Fem pH applicator.

    Figure

    Each tube has a tamper evident seal at the opening of the tube. Replace cap after each use.

    Figure

    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

  • PRINCIPAL DISPLAY PANEL - 50g Tube Box

    NDC 00813-0799-55

    Rx Only

    Fem pHâ„¢
    Therapeutic Vaginal Jelly

    Net Weight 50g
    (1.66 oz.)

    pharmicsINC

    Principal Display Panel - 50g Tube Box

  • INGREDIENTS AND APPEARANCE
    FEM PH 
    acetic acid and oxyquinoline sulfate jelly
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0813-0799
    Route of Administration VAGINAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetic Acid (UNII: Q40Q9N063P) (Acetic Acid - UNII:Q40Q9N063P) Acetic Acid 0.009 g  in 1 g
    Oxyquinoline sulfate (UNII: 61VUG75Y3P) (Oxyquinoline - UNII:5UTX5635HP) Oxyquinoline 0.00025 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Glycerin (UNII: PDC6A3C0OX)  
    Lactic Acid (UNII: 33X04XA5AT)  
    polyethylene glycol 4500 (UNII: TVH7653921)  
    water (UNII: 059QF0KO0R)  
    potassium hydroxide (UNII: WZH3C48M4T)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0813-0799-55 50 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 07/15/1999
    Labeler - Pharmics, Inc. (058560996)
    Establishment
    Name Address ID/FEI Business Operations
    Pernix Manufacturing, LLC 078641814 MANUFACTURE(0813-0799)