Vcf Contraceptive Film, Soluble
FDA Label NDC 52925-112

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Apothecus Pharmaceutical Corp. for the product Vcf Contraceptive (NDC 52925-112). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each film), purpose, use, warnings, sexually transmitted disease (stds) alert, otc - do not use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

  • Begins to dissolve instantly
  • Hormone free
  • Kills sperm on contact

    • Effective up to 3 hours!

    9
    SINGLE
    SEALED
    FILMS

    Contains the Spermicide Doctors Recommend Most

    Principal Display Panel (9 x 1 Film Pouch Box)

    Principal Display Panel (9 x 1 Film Pouch Box)

* Please review the disclaimer below.