NDC 52925-512 Vcf Contraceptive Pre-filled Applicators

Nonoxynol-9

NDC Product Code 52925-512

NDC CODE: 52925-512

Proprietary Name: Vcf Contraceptive Pre-filled Applicators 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.

Non-Proprietary Name: Nonoxynol-9 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.

Product Characteristics

Color(s):
WHITE (C48325)

NDC Code Structure

NDC 52925-512-10

Package Description: 10 APPLICATOR in 1 BOX > 2.55 g in 1 APPLICATOR

NDC 52925-512-25

Package Description: 250 APPLICATOR in 1 CARTON > 2.55 g in 1 APPLICATOR

NDC Product Information

Vcf Contraceptive Pre-filled Applicators with NDC 52925-512 is a a human over the counter drug product labeled by Apothecus Pharmaceutical Corp. The generic name of Vcf Contraceptive Pre-filled Applicators is nonoxynol-9. The product's dosage form is gel, metered and is administered via vaginal form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1597814 and 198765.

Dosage Form: Gel, Metered - A gel preparation, with metered dose valves, which allow for the delivery of a uniform quantity of gel upon each activation.

Product Type: Human Otc Drug 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.

Vcf Contraceptive Pre-filled Applicators Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the 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.

  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)
  • POVIDONE K30 (UNII: U725QWY32X)
  • LACTIC ACID (UNII: 33X04XA5AT)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • EDETATE TRISODIUM (UNII: 420IP921MB)

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.

Labeler Name: Apothecus Pharmaceutical Corp
Labeler Code: 52925
FDA Application Number: part333A 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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.

Start Marketing Date: 06-01-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 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.

Exclude Flag: N - NO 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".

* Please review the disclaimer below.

Vcf Contraceptive Pre-filled Applicators Product Label Images

Vcf Contraceptive Pre-filled Applicators Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

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

Active Ingredient

Nonoxynol-9, (4%)

Purpose

Vaginal Contraceptive

Use

  • For the prevention of pregnancywith condom or alone

Warnings

For Vaginal Use OnlyNot 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

Otc - Stop Use

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

  • For maximum protection against unwanted pregnancy, follow the enclosed directions exactly.Insert one applicatorful into the vagina prior to intercourse (see complete, illustrated directions on package insert).Each applicatorful is effective immediately and up to one hour after application.An additional applicatorful is required prior to each act of intercourse, regardless of time since last application.

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 protocolStore at room temperature, 59° - 86° F (15° - 30° C). Avoid exposure to extremes of hot and cold.

Inactive Ingredients

Purified water, propylene glycol, CMC 7MF, sorbitol solution, PVP K 30, simethicone, lactic acid, methyl paraben, potassium sorbate, sodium benzoate, trisodium EDTA

Questions?

If you have any questions, call our toll-free line at 1-800-879-2393 between 9:00AM and 5:00PM EST, Monday through Friday.

* Please review the disclaimer below.