Label: ADELLINA TATTOO NUMBING- lidocaine cream

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

Drug Label Information

Updated November 15, 2023

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  • Active Ingredient(s)

    Lidocaine 5% g/g. Purpose: Local Anesthetic

  • Purpose

    Local Anesthetic

  • Use

    For the physical or local anesthesia associated with tattoo

  • Warnings

    For external use only.Avoid contact with the eyes Keepaway from heat or flame. Do not use in large quantities,particularly over raw surfaces or blistered areas.

  • Do not use

    • Do not use if Pregnant or breastfeeding, ask a health professionalbefore use.In case of accidental overdose, get medical help or contactthe Poison Control Center immediately. Seal is broken or missing.
  • When using this product

    When using this product do not exceed the recommended dailydosage unless directed by a doctor. certain persons can developallergic reactions to ingredients in this product. do not put thisproduct into the rectum by using finger.

  • Stop use and ask a doctor if

    Stop use and ask a doctor if redness, irritation, swelling, pain,or other symptoms occurs,or lf condition worsens, or if symptomspersist for more than 7 days or clear up and occur again within afew days.

  • Keep out of reach of children

    In case of accidental ingestion, seek medical help immediately.

  • Directions

    Adults: Clean the affected area with mild soap and warm waterand rinse thoroughly.Gently dry by patting with toilet tissue or asoft cloth before application of this product.
    Children under 12 years of age: consult a doctor.

  • Storage and Handling:

    • Keep away from direct sunlight or heat.
      Store at room temperature 15°-30℃(59-86°F).
    • Protect from freezing.
  • Inactive ingredients

    AQUA, Propylene glycol, Carbomer, Glycerin, Disodium edta,Hydroxyacetophenone,1,2-Hexanediol, Mentha Arvensis LeafExtract, Chrysanthellum Indicum Extract, Portulaca OleraceaExtract, PEG-40 hydrogenated castor oil

  • Package Label - Principal Display Panel

    image description50g NDC: 83596-001-01

  • INGREDIENTS AND APPEARANCE
    ADELLINA TATTOO NUMBING 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83596-001
    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
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    MENTHA ARVENSIS LEAF (UNII: A4IWO4DDZ9)  
    CHRYSANTHELLUM INDICUM TOP (UNII: STJ856D1Z0)  
    PURSLANE (UNII: M6S840WXG5)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83596-001-011 in 1 PACKAGE07/28/2023
    150 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01707/28/2023
    Labeler - Aramode (963192477)
    Registrant - Aramode (963192477)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aramode963192477manufacture(83596-001)
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