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  5. Label Information: Vcf Contraceptive Pre-filled Applicators

FDA Label for Vcf Contraceptive Pre-filled Applicators

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USE
    5. WARNINGS
    6. SEXUALLY TRANSMITTED DISEASE (STDS) ALERT
    7. OTC - DO NOT USE
    8. OTC - STOP USE
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. PRINCIPAL DISPLAY PANEL - 2.55 G APPLICATOR BOX

Vcf Contraceptive Pre-filled Applicators Product Label

The following document was submitted to the FDA by the labeler of this product Apothecus Pharmaceutical Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

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


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



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



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



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.


Principal Display Panel - 2.55 G Applicator Box



New!

Compare To
CONCEPTROL®!

VCF®

Vaginal
Contraceptive
Gel

FOR PREVENTION OF PREGNANCY

Pre-Filled Applicators

* Please review the disclaimer below.