Label: VCF CONTRACEPTIVE PRE-FILLED APPLICATORS- nonoxynol-9 gel, metered

  • NDC Code(s): 52925-512-10, 52925-512-25
  • 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 November 11, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Nonoxynol-9, (4%)

  • Purpose

    Vaginal Contraceptive

  • Use

    • for the prevention of pregnancy
    • with condom or alone
  • 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

    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

    • 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 protocol
    • Store 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.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 2.55 g Applicator Box

    New!

    Compare To
    CONCEPTROL®!

    VCF®

    Vaginal
    Contraceptive
    Gel

    FOR PREVENTION OF PREGNANCY

    Pre-Filled Applicators

    • Safe and effective
    • Hormone free
    • Easy to use

    Contains the Spermicide
    Doctors Recommend Most

    10
    PRE-FILLED APPLICATORS
    NET WT. 0.09 oz. (2.55g) EACH

    PRINCIPAL DISPLAY PANEL - 2.55 g Applicator Box
  • INGREDIENTS AND APPEARANCE
    VCF CONTRACEPTIVE PRE-FILLED APPLICATORS 
    nonoxynol-9 gel, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52925-512
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NONOXYNOL-9 (UNII: 48Q180SH9T) (NONOXYNOL-9 - UNII:48Q180SH9T) NONOXYNOL-94 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Sorbitol (UNII: 506T60A25R)  
    Povidone K30 (UNII: U725QWY32X)  
    Lactic Acid, Unspecified Form (UNII: 33X04XA5AT)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Edetate Trisodium (UNII: 420IP921MB)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52925-512-1010 in 1 BOX06/01/2014
    12.55 g in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:52925-512-25250 in 1 CARTON06/01/2014
    22.55 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A06/01/2014
    Labeler - APOTHECUS PHARMACEUTICAL CORP (119263747)