Label: DERMA NUMB PAIN RELIEF- lidocaine hcl gel

  • NDC Code(s): 70188-005-01, 70188-005-04
  • Packager: A.T.S. Laboratories, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 14, 2024

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  • Active Ingredients

    Lidocaine HCL 4.0% w/w

  • Purpose

    External Analgesic

  • Uses

    For temporary relief of pain and itching associated with minor cuts or minor skin irritations.

  • Warnings

    ​For external use only

    Avoid contact with eyes

  • DO NOT USE

    ​Do not use ​in large quantities, particularly over raw surfaces or blistered areas

  • STOP USE

    ​Stop use and ask doctor if​

    ​• Condition worsens, or if symptoms persist for more then 7 days or clear up and occur again with a few days.  Discontinue use.

  • KEEP OUT OF REACH OF CHILDREN

    ​Keep out of reach of children​

    • If product is swallowed, get medical help or contact a poison control center right away.

  • Directions

    For adults and children two-years or older: Apply to affected area not more than 3 to 4 times daily.  Children under 2 years of age: consult a physician.

  • Inactive Ingredients

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

  • Other Information

    Protect this product from excessive heat and direct sun.

  • Questions or Comments?

    954-492-9898

  • PRINCIPAL DISPLAY PANEL

    1oz Label1oz Label

    4oz Label4oz Label

  • INGREDIENTS AND APPEARANCE
    DERMA NUMB PAIN RELIEF 
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70188-005
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70188-005-0128 g in 1 PACKAGE; Type 0: Not a Combination Product07/01/2015
    2NDC:70188-005-04113 g in 1 PACKAGE; Type 0: Not a Combination Product07/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM07/01/2015
    Labeler - A.T.S. Laboratories, LLC (080013331)
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