Label: GYNOL II EXTRA STRENGTH- nonoxynol gel

  • 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 December 1, 2020

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  • Active ingredient

    Nonoxynol-9 (3%) (100 mg per applicatorful)............................................Vaginal Contraceptive

  • Uses

    For the prevention of pregnancy.

    With condom or alone.

  • WARNINGS

    For vaginal use only.

    Not for rectal (anal) use.

    Sexually transmitted diseases (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 your sex partner is infected, choose another form of birth control.

    Stop use and ask a doctor if you or your partner gets burning, itching, a rash, or other irritation or 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.

    Each applicatorful is effective immediately and up to one hour after application.

  • DOSAGE & ADMINISTRATION

    Insert one applicatorful into the vagina prior to intercourse (see complete, illustrated directions on the package insert).

    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.

    Store at room temperature, 20° - 25° C (68° -77° F). Avoid exposure to extremes of hot or cold.

  • Inactive ingredients

    Lactic acid, methylparaben, povidone, propylene glycol, purified water, sodium carboxymethylcellulose, sorbic acid, sorbitol solution.

  • PRINCIPAL DISPLAY PANEL

    mm1.jpg

    Carton Label

    MM2.jpg
    Bottle Label

  • INGREDIENTS AND APPEARANCE
    GYNOL II  EXTRA STRENGTH
    nonoxynol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34362-0302
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NONOXYNOL-9 (UNII: 48Q180SH9T) (NONOXYNOL-9 - UNII:48Q180SH9T) NONOXYNOL-93.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBIC ACID (UNII: X045WJ989B)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    POVIDONE K29/32 (UNII: 390RMW2PEQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34362-0302-51 in 1 CARTON12/01/2020
    1NDC:34362-0302-181 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2011
    Labeler - Caldwell Consumer Health LLC (828558713)
    Registrant - Lornamead (126440440)
    Establishment
    NameAddressID/FEIBusiness Operations
    DPT Laboratories832224526manufacture(34362-0302) , pack(34362-0302)
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