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

VCF CONTRACEPTIVE PRE-FILLED APPLICATORS by

Drug Labeling and Warnings

VCF CONTRACEPTIVE PRE-FILLED APPLICATORS by is a Otc medication manufactured, distributed, or labeled by APOTHECUS PHARMACEUTICAL CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52925-512
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NONOXYNOL-9 (UNII: 48Q180SH9T) (NONOXYNOL-9 - UNII:48Q180SH9T)	NONOXYNOL-9	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52925-512-10	10 in 1 BOX	06/01/2014
1		2.55 g in 1 APPLICATOR; 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	06/01/2014

Labeler - APOTHECUS PHARMACEUTICAL CORP (119263747)