Label: ETADERM NUMBING CREAM- lidocaine cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 14, 2024

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  • Active Ingredients

    Lidocaine 5 %

    Purpose

    Local Anesthetic

  • Uses:

    For temporary relief of local and Anorectal discomfort associated with Anorectal discomfort or inflammation

  • Warnings:

    For external use only

    When using this product

    • ▪ do not get into eyes. ▪ do not exceed the recommended daily dosage unless directed by a doctor ▪ do not put this product into the rectum by using fingers or any mechanical device or applicator.

    Stop use and ask a doctor if

    • ▪ condition worsens or does not improve within 7 days. ▪ in case of bleeding, consult a doctor promptly ▪ 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.

    Keep out of reach of children.

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

    If pregnant or breast-feeding, 

    ask a health professional before use

  • Directions:

    ▪ Cleanse affected area and gently dry. Apply externally to the affected area up to 6 times daily, especially at night, in the morning or after each bowel movement ▪ Children under 12 years of age: consult a doctor.

  • Inactive Ingredients:

    Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, Vitamin E Acetate.

  • Questions?

    424-354-4370

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ETADERM NUMBING CREAM 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84180-001
    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 (UNII: 0A5MM307FC)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84180-001-0144 g in 1 TUBE; Type 0: Not a Combination Product07/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01707/15/2022
    Labeler - NUEPHASE LLC (118900101)
    Registrant - Bridgeview Investments LLC (035014854)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions LLC081030372manufacture(84180-001)
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