VCF® CONTRACEPTIVE GEL PRE-FILLED APPLICATORS

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.

OTC - DO NOT USE SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if you or your partner get burning, itching, a rash, or other irritation of the vagina or penis.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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