Label: DERMANUMB ANALGESIC- lidocaine hcl gel

  • NDC Code(s): 70188-006-01
  • Packager: A.T.S. Laboratories, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 14, 2022

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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, Alcohol SDA-40, Aloe Barbadensis Leaf Extract, Capryly Glycol, Carbomer, Disodium EDTA, Glycerin, Menthol, Methylisothiazolinone, Propylene Glycol, Schidigera (Yucca) Root Extract, Triethanolamine, Water.

  • Other Information

    Protect this product from excessive heat and direct sun.

  • Questions or Comments?

    954-492-9898

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    DERMANUMB ANALGESIC 
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70188-006
    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)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
    MENTHOL (UNII: L7T10EIP3A)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70188-006-0157 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 not finalpart34807/01/2015
    Labeler - A.T.S. Laboratories, LLC (080013331)
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