Label: SERUM X- lidocaine hydrochloride gel

  • NDC Code(s): 82317-001-01, 82317-001-30
  • Packager: AO Biologix, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2024

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  • Active ingredient

    Lidocaine Hydrochloride 0.5%

  • Purpose

    Lidocaine Hydrochloride 0.5%...............Topical Analgesic

  • Uses

    For the temporary relief of pain

  • Warnings

    For external use only

    Do not use

    • in large quantities, particularly over raw surfaces or blistered areas

    When using this product

    • avoid contact with the eyes

    Stop use and ask doctor if

    • condition worsens
    • any allergic reaction occurs
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant or breastfeeding,ask a health professional before use.

    Keep out of the reacho f children.If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 2 years of age and older:apply to affected area not more than 3 to 4 times daily

    Children under 2 years of age:consult a doctor

  • Other information

    • store in a cool, dry place away from light
    • this package is child-resistant
  • Inactive ingredients

    Water, Hydroxyethylcellulose, Disodium Phosphate, Sodium Phosphate, Methylparaben, Superoxide Dismutase, Propylparaben

  • Questions or comments?

    Call 855-910-1252 Monday-Friday; 9am-5pm MST.

    SerumX.com

  • PRINCIPAL DISPLAY PANEL

    AO Biologix

    Serum X

    Pain Relief Gel

    Fast Acting Lidocaine

    With Antioxidant Properties

    30mL/1 Fl. oz.

    1

    2

  • INGREDIENTS AND APPEARANCE
    SERUM X 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82317-001
    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 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82317-001-301 in 1 CARTON04/21/2022
    130 g in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:82317-001-011 in 1 PACKAGE07/01/2022
    20.5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/21/2022
    Labeler - AO Biologix, LLC (102188692)
    Establishment
    NameAddressID/FEIBusiness Operations
    TRI-PAC, INC.020844956manufacture(82317-001)
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