Fem Ph

Acetic Acid And Oxyquinoline Sulfate

Pharmics, Inc.
Human Prescription Drug
NDC 0813-0799

Fem Ph also known as Acetic Acid And Oxyquinoline Sulfate is a human prescription drug labeled by 'Pharmics, Inc.'. National Drug Code (NDC) number for Fem Ph is 0813-0799. This drug is available in dosage form of Jelly. The names of the active, medicinal ingredients in Fem Ph drug includes Acetic Acid - .009 g/g Oxyquinoline Sulfate - .00025 g/g . The currest status of Fem Ph drug is Active.

Drug Information:

Drug NDC:	0813-0799
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Fem Ph
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Acetic Acid And Oxyquinoline Sulfate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Pharmics, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Jelly
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	ACETIC ACID - .009 g/g OXYQUINOLINE SULFATE - .00025 g/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	VAGINAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED DRUG OTHER
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	15 Jul, 1999
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	18 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2024
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Pharmics, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	543873 1243480
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	Q40Q9N063P 61VUG75Y3P
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
0813-0799-55	50 g in 1 TUBE (0813-0799-55)	15 Jul, 1999	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Fem Ph

Acetic Acid And Oxyquinoline Sulfate

Jelly
Pharmics, Inc.
NDC: 0813-0799

Product Elements:

Fem ph acetic acid and oxyquinoline sulfate glycerin lactic acid polyethylene glycol 4500 water potassium hydroxide acetic acid acetic acid oxyquinoline sulfate oxyquinoline

Drug Interactions:

Drug interactions no incidence of drug interactions has been reported with concomitant use of fem ph and any other medication.

Indications and Usage:

Indications and usage fem ph is indicated as adjunctive therapy in those cases where restoration and maintenance of vaginal acidity is desirable.

Warnings:

Warnings no serious adverse reactions or potential safety hazard have been reported with the use of fem ph .

General Precautions:

General no special care is required for the safe and effective use of fem ph .

Dosage and Administration:

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.

Contraindications:

Contraindications none known.

Adverse Reactions:

Adverse reactions occasional cases of local stinging and burning have been reported.

Drug Interactions:

Drug interactions no incidence of drug interactions has been reported with concomitant use of fem ph and any other medication.

Use in Pregnancy:

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.

Description:

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:

Clinical pharmacology fem ph acts to restore and maintain normal vaginal acidity through its buffered action.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

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

How Supplied:

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 59Â°-86Â°f (15Â°-30Â°c)

Package Label Principal Display Panel:

Principal display panel - 50g tube box ndc 00813-0799-55 rx only fem phâ¢ therapeutic vaginal jelly net weight 50g (1.66 oz.) pharmicsinc label

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.