Label: LIQUID SEX- lidocaine gel

  • Category: HUMAN OTC DRUG LABEL

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 14, 2017

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  • ACTIVE INGREDIENT

    Lidocaine 2%

  • PURPOSE

    Anorectal

  • INDICATIONS & USAGE

    For temporary relief of pain, soreness or burning in the perianal area.

  • WARNINGS

    • For external use only. Do not use product with a mechanical device.
    • Certain persons can develop allergic reactions to ingredients in this product. If the symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.
    • Do not exceed the daily recommended dosage.
    • Do not apply onto cracked or broken skin.
    • In case of any bleeding or irritation, discontinue use and consult a doctor.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep this and all drugs out of reach of children. In case of accidental overdose, seek medical help or call a Poison Control Center right away.
    • As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.
    • Do not exceed recommended dosage.
  • DOSAGE & ADMINISTRATION

    • Cleanse affected area with mild soap and water. Gently dry by patting or blotting with toilet tissue or a soft cloth before application.
    • Apply externally to the affected area up to 6 times daily.
  • OTHER SAFETY INFORMATION

    • Store at room temperature 20° - 25°C (68°-77°F)
    • Tamper-Evident: Do not use if tamper evident seal on the outside of the container is broken or missing.
  • INACTIVE INGREDIENT

    Cellulose Gum, Diazolidinyl Urea, Glycerin, Isopentyldiol, Methylparaben, Propylparaben, Purified Water (Aqua).

  • PRINCIPAL DISPLAY PANEL

    1039093

  • INGREDIENTS AND APPEARANCE
    LIQUID SEX 
    lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69797-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE2.36 g  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOPENTYLDIOL (UNII: 19NOL5474Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69797-101-01118 mL in 1 TUBE; Type 0: Not a Combination Product12/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34612/14/2017
    Labeler - WSM Investment LLC. Topco Sales (040346439)
    Establishment
    NameAddressID/FEIBusiness Operations
    WSM Investment LLC. Topco Sales040346439manufacture(69797-101)
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