STAMA PRO (LIDOCAINE) SPRAY [CERNO PHARMACEUTICALS]

STAMA PRO (LIDOCAINE) SPRAY [CERNO PHARMACEUTICALS]
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NDC 70107-302-09
Set ID 19f01eb1-e9f0-447b-af94-91efc6e99aa6
Category HUMAN OTC DRUG LABEL
Packager Cerno Pharmaceuticals
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • 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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