Label: VCF CONTRACEPTIVE- nonoxynol-9 aerosol, foam

  • 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

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Nonoxynol-9, 12.5%

  • 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.

    Contents under pressure. Do not puncture or incinerate container. Do not store above 120° F.

  • Directions

    • before using this product, read the enclosed package insert for complete directions and information
    • insert one applicator full of foam in the vagina no more than one hour before each act of intercourse
    • if this product is used together with another contraceptive method, there will probably be better protection against pregnancy
    • if douching is desired, always wait at least 6 hours after intercourse before douching
    • see enclosed instructions for cleaning the applicator after each use
  • 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.
  • Inactive ingredients

    benzoic acid, cellulose gum, cetyl alcohol, fragrance, glacial acetic acid, methylparaben, phosphoric acid, polyvinyl alcohol, propellant A-31, propylene glycol, purified water, sorbic acid, stearamidoethyl diethylamine, stearic acid.

  • 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 - 17 g Can Box

    New
    Applicator!

    Easy To Use

    VCF®

    Vaginal
    Contraceptive
    Foam

    FOR PREVENTION OF PREGNANCY

    • Safe & effective
    • Hormone free
    • Contains the
      spermicide doctors
      recommend most

    Laboratory Tested
    Contraceptive
    Works Instantly!

    Net wt. 0.6 oz (17g)

    Principal Display Panel - 17 g Can Box
  • INGREDIENTS AND APPEARANCE
    VCF CONTRACEPTIVE 
    nonoxynol-9 aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52925-312
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NONOXYNOL-9 (UNII: 48Q180SH9T) (NONOXYNOL-9 - UNII:48Q180SH9T) NONOXYNOL-9125 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52925-312-141 in 1 BOX06/01/1997
    117 g in 1 CAN; Type 0: Not a Combination Product
    2NDC:52925-312-0617 g in 1 CAN; Type 0: Not a Combination Product06/01/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A06/01/1997
    Labeler - APOTHECUS PHARMACEUTICAL CORP (119263747)
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