Label: VCF CONTRACEPTIVE- nonoxynol-9 film, soluble

  • NDC Code(s): 52925-112-01
  • Packager: APOTHECUS PHARMACEUTICAL CORP.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 11, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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.

    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

    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.)

  • SPL UNCLASSIFIED SECTION

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

  • 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
  • INGREDIENTS AND APPEARANCE
    VCF CONTRACEPTIVE 
    nonoxynol-9 film, soluble
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52925-112
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NONOXYNOL-9 (UNII: 48Q180SH9T) (NONOXYNOL-9 - UNII:48Q180SH9T) NONOXYNOL-9280 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52925-112-019 in 1 BOX06/01/1988
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A06/01/1988
    Labeler - APOTHECUS PHARMACEUTICAL CORP. (119263747)