Label: SERUM X- lidocaine hydrochloride gel

  • NDC Code(s): 82317-001-01, 82317-001-30
  • Packager: AO Biologix, LLC
  • Category: HUMAN OTC DRUG LABEL

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 April 21, 2022

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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 not finalpart34804/21/2022
    Labeler - AO Biologix, LLC (102188692)
    Establishment
    NameAddressID/FEIBusiness Operations
    TRI-PAC, INC.020844956manufacture(82317-001)
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