Label: SAMNYTE TATTOO NUMBING CREAM- lidocaine emulsion

  • NDC Code(s): 82929-010-01, 82929-010-02, 82929-010-03
  • Packager: Sainite Trading Shenzhen Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 23, 2024

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  • Active Ingredients

    Lidocaine 5%

  • Purpose

    Topical Anesthetic

  • Uses

    For temporary relief of local discomfort, itching, pain, soreness, or burning in the perianal area associated with anorectal disorders.

  • Warnings

    For external use only

    Do not this product

    Pregnant or breastfeeding, ask a health professional before use.

    When using this product

    Do not exceed the recommended daily dosage unless directed by a doctor
    Do not put into the rectum by using fingers or any mechanical device or applicator.

    Stop use and ask a doctor if

    Condition worsens, or does not imprcve within 7 days. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treateddoes not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Discontinue use

    Keep out of reach of children

    In case of accidental ingestion, seek madical attention immediately

  • Directions

    Adults and Children 12 years and older: When practical, cleanse the affected area with mild soap and warm water and rinse thotoughly.
    Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product. Apply externally to the affected area uo to 6 times daily.

  • Other Informatiom

    ● Keep away from direct sunlight or heat
    ● Store in room temperature (59-86°F/15-30°C)

  • Inactive Ingredients

    Aloe barbadebsis leaf juice (Aloe vera), Water, Lecithin (Soybean), Propylene Glycol, Tocopheryl Acetate, Carbomer, Menthol, Triethanolamine

  • 30ml / 1.06 Fl.Oz

    82929-010-01

  • 40ml / 1.41 Fl.Oz

    82929-010-02

  • 60ml / 2.12 Fl.Oz

    82929-010-03

  • INGREDIENTS AND APPEARANCE
    SAMNYTE TATTOO NUMBING CREAM 
    lidocaine emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82929-010
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MENTHOL (UNII: L7T10EIP3A)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82929-010-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/24/2024
    2NDC:82929-010-0240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/24/2024
    3NDC:82929-010-0360 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/24/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01501/24/2024
    Labeler - Sainite Trading Shenzhen Co., Ltd. (418973870)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sainite Trading Shenzhen Co., Ltd.418973870label(82929-010) , manufacture(82929-010)
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