ZENSA (LIDOCAINE) CREAM [ALERA SKIN CARE PRODUCTS INC.]

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ZENSA (LIDOCAINE) CREAM [ALERA SKIN CARE PRODUCTS INC.]
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NDC 69805-786-01
Set ID f56146b6-3c11-4608-a6ab-6142f27e9ac3
Category HUMAN OTC DRUG LABEL
Packager Alera Skin Care Products Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART346
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  • Active ingredient

    Lidocaine 5%

  • Purpose

    Topical Anaesthetic

  • Uses

    • For the temporary relief of local discomfort associated with anorectal disorders
    • For the temporary relief of pain, soreness, and burning
  • Warnings

    ​For external use only.

    When using this product

    • avoid contact with eyes
    • do not exceed the recommended daily dosage unless directed by a physician
    • do not put this product into the rectum by using fingers or any mechanical device or applicator
    • certain persons can develop allergic reactions to ingredients in this product.  If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor
  • Stop use and ask a doctor if

    • condition worsens or does not improve within 7 days
    • bleeding occurs
  • Keep out of reach of children

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

  • Directions

    • Adults: when practical, cleanse the affected area with mild soap, and warm water and rinse thoroughly.  Gently dry by patting or blottig with toilet tissue or a soft cloth before application of this product.  Children under 12 years of age: consult a physician.
    • Apply externally to the affected area up to 6 times daily
  • Other information

    See enclosed consumer leaflet.

    Store at 15°C to 30°C.  Protect from freezing

  • Inactive ingredients

    Benzyl Alcohol, Carbopol, Lecithin, Propylene Glycol, Vitamin E Acetate, Purified Water

  • PRINCIPAL DISPLAY PANEL

    ​NDC 69805-786-01​

    ​ZENSA

    TOPICAL ANESTHETIC CREAM - ANORECTAL

    WITH 5% LIDOCAINE

    30 g

    zensa

  • INGREDIENTS AND APPEARANCE
    ZENSA 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69805-786
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69805-786-011 in 1 CARTON01/04/2016
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/04/2016
    Labeler - Alera Skin Care Products Inc. (202686093)
    Registrant - Alera Skin Care Products Inc. (202686093)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs, Inc926831603manufacture(69805-786)
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