NDC 52925-112 Vcf Contraceptive
Nonoxynol-9 Film, Soluble Vaginal

Product Information

Product Code52925-112
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Vcf Contraceptive
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Nonoxynol-9
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormFilm, Soluble - A thin layer or coating which is susceptible to being dissolved when in contact with a liquid.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Vaginal - Administration into the vagina.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Apothecus Pharmaceutical Corp.
Labeler Code52925
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
part333A
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
06-01-1988
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2022
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Characteristics

Color(s)WHITE (C48325)

Product Packages

NDC 52925-112-01

Package Description: 9 POUCH in 1 BOX > 1 FILM, SOLUBLE in 1 POUCH

Product Details

Vcf Contraceptive is a human over the counter drug product labeled by Apothecus Pharmaceutical Corp.. The generic name of Vcf Contraceptive is nonoxynol-9. The product's dosage form is film, soluble and is administered via vaginal form.


What are Vcf Contraceptive Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:


Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYVINYL ALCOHOL (UNII: 532B59J990)
  • WATER (UNII: 059QF0KO0R)


* Please review the disclaimer below.

Vcf Contraceptive Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Drug Facts

Distributed By: Apothecus Pharmaceutical Corp., Oyster Bay, NY 11771


Active Ingredient (In Each Film)



Nonoxynol-9, 28%


Purpose



Vaginal contraceptive


Use



for the prevention of pregnancy


Warnings



  • For Vaginal Use Only
  • Not for rectal (anal) use

Sexually Transmitted Disease (Stds) Alert



This product does not protect against HIV/AIDS or other STDs and may increase the risk of getting HIV from an infected partner.


Otc - Do Not Use



Do not use if you or your sex partner has HIV/AIDS. If you do not know if you or your sex partner is infected, choose another form of birth control


When Using This Product



  • you may get vaginal irritation (burning, itching or a rash)

Stop Use And Ask A Doctor If



  • you or your partner get burning, itching, a rash, or other irritation of the vagina or penis

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • before using this product, read the enclosed package insert for complete directions and information
  • be sure your fingers are dry before touching the film
  • insert one film and place as far into the vagina as possible against the cervix
  • insert VCF® not less than 15 minutes and not more than 3 hours before intercourse
  • use one film before each act of intercourse

Other Information



  • When used correctly every time you have sex, latex condoms greatly reduce, but do not eliminate, the risk of catching or spreading HIV, the virus that causes AIDS.
  • Use a latex condom without nonoxynol-9 if you or your sex partner has HIV/AIDS, multiple sex partners, or other HIV risk factors.
  • VCF® is tested by independent laboratories for determination of sperm inactivating qualities, using the I.P.P.F. agreed protocol
  • Store at 58° - 86°F (15°-30°C)

Inactive Ingredients



glycerin, polyvinyl alcohol, purified water


Questions?



1-800-879-2393 (9-5 E.S.T.)


Principal Display Panel - 9 X 1 Film Pouch Box



VCF®
Vaginal
Contraceptive
Film®
FOR PREVENTION OF PREGNANCY

* Please review the disclaimer below.