Label: STAMA PRO- lidocaine spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 11, 2017

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  • ACTIVE INGREDIENT

    Each milliliter contains
     Active Ingredient Purpose
     Lidocaine Hydrochloride 9.6% Male Genital Desensitizer

  • INACTIVE INGREDIENT

    Methylparaben, Propylparaben, Carboxymethyl Cellulose Sodium, Deionized Water.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center.

  • INDICATIONS & USAGE

    Helps in the prevention of premature ejaculation.

  • WARNINGS

    For external use only. ■ Avoid contact with the eyes.

  • Stop use and ask a doctor:

    ■ If you or your partner develop a rash or irritation such as burning or itching. If symptoms persist, consult a doctor.

    ■ Premature ejaculation may be due to a condition requiring medical supervision. If this product, used as directed does not provide relief, discontinue use and consult a doctor.

  • DOSAGE & ADMINISTRATION

    Remove the protective cap. Press the actuator down repeatedly until product dispenses to prime spray pump.
    Apply 3 or more sprays, not to exceed 10, to head and shaft of penis 8 minutes before intercourse, or use as directed by a
    doctor. Wash product off after intercourse. After spraying, place the cap back on.

  • PURPOSE

    Male Genital Desensitizer

  • Other Information

    ■ Keep away from fire and flames. ■ Store at 20-25°C (68-77°F)

    Made in the U.S.A.

  • PRINCIPAL DISPLAY PANEL

    Label Image
  • INGREDIENTS AND APPEARANCE
    STAMA PRO 
    lidocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70107-302
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE96 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70107-302-0913.5 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/11/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34801/11/2017
    Labeler - Cerno Pharmaceuticals (079821037)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cerno Pharmaceuticals079821037MANUFACTURE(70107-302)
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