Label: INKCOUTURE TATTOO NUMBING .SPRAY- tattoo numbing spray liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 1, 2023

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  • Active Ingredient

    Lidocaine 4%

  • Purpose

    External Analgesic

  • Use

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

  • Warnings

    WARNINGS (FOR EXTERNAL USEONLY)
    DO NOT USE THIS PRODUCT IF
    *Pregnant or breastfeeding, ask a health professional before use.
    *In case of accidental overdose, contact a doctor or Poison Control Center immediately.
    *Seal is broken or missing.

  • When Using

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

  • Stop Use

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

  • Keep Oot Of Reach Of Children

    In case of accidental ingestion, seek medical attention immediately.

  • Directions

    1.Before the spray's application, wash hands thoroughly and wear disposable tattoo gloves.
    2.Clean the area of the body receiving the tattoo . Dry completely.
    3. Apply a thick amount of numbing spray to the cleaned area and rub in thoroughly.Cover with plastic wrap.
    4. Leave spray and wrap in place for 30-45minutes. Wipe the spray away and clean the area thoroughly and ready for your pain free tattoo.

  • Other information

    STORAGE
    *Store at cool and dry room
    temperature.

  • Inactive ingredients

    Glycerin, Butylene Glycol, Xanthan
    Gum,Sodium Hyaluronate
    Butyrospermum Parkii(Shea Butter)
    Oil, Simmondsia Chinensis(Jojoba)
    Seed Oil, Squalane, Dimethicone,Glyceryl
    Stearate, Cetearyl Glucoside.Getearyl
    Alcohol, Tocopherol,
    Menthol.Borneol

  • Questions

    inkcouturestore.com

    info@inkcouturestore.com
    951-265-8930

  • PRINCIPAL DISPLAY PANEL

    01

  • INGREDIENTS AND APPEARANCE
    INKCOUTURE TATTOO NUMBING .SPRAY 
    tattoo numbing spray liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83565-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL (UNII: 724GKU717M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MENTHOL (UNII: L7T10EIP3A)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SQUALANE (UNII: GW89575KF9)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    BORNEOL (UNII: M89NIB437X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83565-006-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/01/2023
    Labeler - Stellans Inc. (111157321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Stellans Inc.111157321label(83565-006) , manufacture(83565-006)
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