Label: MYDERM- lidocaine gel

  • 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 10, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient

    Lidocaine ............. 0.5%

  • PURPOSE

    Lidocaine 0.5% ............. Pain Reliever

  • INDICATIONS & USAGE

    Temporary relief of pain and itching due to

    - sunburn - minor burn - insect bites - minor cuts - scraps

  • WARNINGS

    Warnings

    For external use only

    When using this product keep out of eyes

    Rinse with warter to remove

  • STOP USE

    Sop use and ask a doctor

    system persist for more than 7 days.

  • 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.

  • DOSAGE & ADMINISTRATION

    Direction

    Adults and children 2 years and older: aooly to affected area not more that 3-4 times a day

    Children under 2 years of age: consult a physician.

  • INACTIVE INGREDIENT


    Inactive Ingredients: Aloe Barbadensis Leaf Extract, Carbomer, Diazolidinyl Urea, Disodium EDTA, Glycerin, Isopropyl Alcohol, Menthol, Polysorbate 80, Propylene Glycol, Triethanolamine, Water, Yellow 5.

  • PRINCIPAL DISPLAY PANEL

    Pain Reliever ALOE GEL Lidocain HCI 0.5%

  • INGREDIENTS AND APPEARANCE
    MYDERM 
    lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72667-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MENTHOL (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL 2-STEARATE (UNII: 5317AOR1RX)  
    TROLAMINE SALICYLATE (UNII: H8O4040BHD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DISODIUM HEDTA (UNII: KME849MC7A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    FD&C YELLOW NO. 5 FREE ACID (UNII: 6TP696149N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72667-008-01237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/26/2019
    Labeler - Inspec Solutions LLC. (081030372)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions LLC.081030372manufacture(72667-008)
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