Label: VCF CONTRACEPTIVE- nonoxynol-9 aerosol, foam
Contains inactivated NDC Code(s)
NDC Code(s): 52925-312-06, 52925-312-14
- 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.
Updated December 11, 2018
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- 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.
- before using this product, read the enclosed package insert for complete directions and information
- insert one applicator full of foam in the vagina no more than one hour before each act of intercourse
- if this product is used together with another contraceptive method, there will probably be better protection against pregnancy
- if douching is desired, always wait at least 6 hours after intercourse before douching
- see enclosed instructions for cleaning the applicator after each use
- Other Information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 17 g Can Box
INGREDIENTS AND APPEARANCE
nonoxynol-9 aerosol, foam
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52925-312 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NONOXYNOL-9 (UNII: 48Q180SH9T) (NONOXYNOL-9 - UNII:48Q180SH9T) NONOXYNOL-9 125 mg in 1 g Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) CETYL ALCOHOL (UNII: 936JST6JCN) ACETIC ACID (UNII: Q40Q9N063P) METHYLPARABEN (UNII: A2I8C7HI9T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52925-312-14 1 in 1 BOX 06/01/1997 1 17 g in 1 CAN; Type 0: Not a Combination Product 2 NDC:52925-312-06 17 g in 1 CAN; Type 0: Not a Combination Product 06/01/1997 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333A 06/01/1997 Labeler - APOTHECUS PHARMACEUTICAL CORP (119263747)