Label: NUMB- lidocaine 5% cream

  • NDC Code(s): 82429-203-01
  • Packager: Gabar Health Sciences Corp.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 21, 2023

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  • Active Ingredient

    Lidocaine 5% W/W

  • Purpose

    Local Anesthetic

  • Uses

    For the temporary roliot of local and anorectal discomfort associated with anorectal disorder or inflammation.

  • Warnings (For external use only)

    Do not use this product if

    • Pregnant or breastfeeding, ask a health professional before use.
    • In case of accidental overdose, get medical help or contact Poison Control Center immediately.
    • tamper evident "Do not use this product" If seal is broken or missing.

    When using this product

    • do not exceed the recommended daily dosage unless directed by doctor.
    • Certain persons can develop allergic reactions to ingredients in this product.
    • Do not put this product into the rectum by using ‑nger or any medical device or applicator.

    Stop use and ask doctor if

    the symptoms being treated does not subside, or if redness, Irritation, swelling pain or other symptoms develop or increase.

  • Keep out of reach of the children.

    In case of accidental ingestion, sook modical attention immediately.

  • Directions

    • Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
    • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
    • Apply up to 6 times a day.
    • Children un 12 years of age consult a doctor.
  • Other Information

    • Keep away from direct sunlight or heat.

    • Store at room temperature 15° to 30°C (59° to 86°F)

  • Inactive ingredient

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

  • Questions ?

    (407) 737-9424

  • Principal Primary Panel

    NUMB CREAM

    NDC 82429-203-01

    Lidocaine Cream 5%

    NET WT 1.35 OZ (38g)

    label

  • INGREDIENTS AND APPEARANCE
    NUMB 
    lidocaine 5% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82429-203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82429-203-011 in 1 CARTON10/10/2022
    138 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01510/10/2022
    Labeler - Gabar Health Sciences Corp. (118401847)
    Registrant - Gabar Health Sciences Corp. (118401847)
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