Label: FEM PH- acetic acid and oxyquinoline sulfate jelly
- NDC Code(s): 0813-0799-55
- Packager: Pharmics, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
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Updated November 5, 2018
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- SPL UNCLASSIFIED SECTION
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.Close
- Clinical Pharmacology
Fem pH acts to restore and maintain normal vaginal acidity through its buffered action.Close
- Indications and Usage
Fem pH is indicated as adjunctive therapy in those cases where restoration and maintenance of vaginal acidity is desirable.Close
No serious adverse reactions or potential safety hazard have been reported with the use of Fem pH.Close
No incidence of drug interactions has been reported with concomitant use of Fem pH and any other medication.
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)
No long-term studies in animals have been performed to evaluate carcinogenic potential.
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.Close
- 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.Close
- 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
Houston, TX 77099
Salt Lake City, UT 84119
- Therapeutic Vaginal Jelly
Directions for using Fem pH applicator.
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
Therapeutic Vaginal Jelly
Net Weight 50g
- INGREDIENTS AND APPEARANCE
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; Type 0: Not a Combination Product 07/15/1999 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)