VCF CONTRACEPTIVE (NONOXYNOL-9) FILM, SOLUBLE [APOTHECUS PHARMACEUTICAL CORP.]

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VCF CONTRACEPTIVE (NONOXYNOL-9) FILM, SOLUBLE [APOTHECUS PHARMACEUTICAL CORP.]
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NDC 52925-112-01
Set ID 92f8eee8-2456-4baf-a85e-1335c80d7fcd
Category HUMAN OTC DRUG LABEL
Packager APOTHECUS PHARMACEUTICAL CORP.
Generic Name
Product Class
Product Number
Application Number PART333A
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  • 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)
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