Label: DERMA NUMB- lidocaine hci spray

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 3, 2012

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  • Active Ingredients

    Lidocaine HCI

  • Purpose

    Topical Anesthetic

  • Uses

    Temporarily relieves pain from tattoo procedures.

  • Directions

    First test product to sensitivity to skin.

    Once skin is broken or outline is done, apply derma numb generously to tattooed area.

    Wait two minutes for anesthetic to take affect, re-apply derma numb to tattoo area as needed through out the tattoo process for comfort. Discontinue use if sensitivity occurs. Do not use on face.

  • Warnings

    External Use Only

    Avoid contact with the eyes

  • Do Not Use

    If you have any known allergy or sensitivity to any of these ingredients in this product. Discontinue use and seek medical attention.

  • Stop Use and ask a doctor if

    • skin becomes irritated • condition worsens or symptoms last more than7 days • symptoms clear up and reoccur with a few days

  • Inactive ingredients

    Water, Propylene Glycol, Achillea Millefolium (Yarrow) Extract, Yucca Glauca Root Extract, Citric Acid, Sodium Metabisulfate, Caprylyl Glycol, Disodium EDTA, Methylisothiazolinone.

  • Other Information

    This product was manufactured for Atlas Tat, Inc.

    Any questions call 954-492-9898 or check out the web @ dermnumb.com

  • PRINCIPAL DISPLAY PANEL

    DermaNumbLabel_1oz_r1

  • INGREDIENTS AND APPEARANCE
    DERMA NUMB 
    lidocaine hci spray
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53200-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    YUCCA GLAUCA ROOT (UNII: 1A15YBH7N1)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53200-001-0128.35 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34807/15/2012
    Labeler - Atlas Tat Inc. (061275633)
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