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 January 11, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each film)
- 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
- 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
- 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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 9 x 1 Film Pouch Box
INGREDIENTS AND APPEARANCE
nonoxynol-9 film, soluble
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52925-112 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NONOXYNOL-9 (UNII: 48Q180SH9T) (NONOXYNOL-9 - UNII:48Q180SH9T) NONOXYNOL-9 280 mg Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52925-112-01 9 in 1 BOX 06/01/1988 1 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333A 06/01/1988 Labeler - APOTHECUS PHARMACEUTICAL CORP. (119263747)