Label: AUEBLISS- lidocaine cream

  • 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 5, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Lidocaine HCl 5%

  • Purpose

    Topical analgesic/Anesthetic

  • Uses

    For the temporary relief of minor pain, irritation and itching

  • Warnings

    For external use only.
    When using this product Avoid contact with eyes.
    Do not apply to wounds or damaged, broken or irritated skin
    Stop use and ask a doctor If• Condition worsens. • Irritation develops. Redness appears. • Symptoms persist for more than 7 days or clear up and occurs again within a few days.

    Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away. Emergency Number: 1-800-222-1222

    IF PREGNANT OR BREASTFEEDING, ask a heath professional before use

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Adults and children over 12 years:
    • Apply a thin layer to affected area every 6 to 8 hours.
    • Wash hands with soap and water immediately after use.
    • Children 12 years or younger: ask a doctor.

  • Other Information

    Store at 15•-30• C (59'-86' F).

  • Inactive ingredients

    Aqua, Caprylic/Capric Triglyceride, Butylene Glycol, Ethoxydiglycol, Ammonium AcryloyldimethyltaurateNP Copolymer, Squalane, Aloe Barbadensis (Aloe Vera) Leaf Juice, Allantoin, Tocopherol (Vitamin E), Persea Gratissima (Avocado) Oil, Hydroxyethyl Acrylate, Sodium Acryloyldimethyl Tau rate Copolymer, Polyacrylate Crosspolymer-6, Phenoxyethanol, Xanthan Gum, Ethylhexylglycerin, Lecithin.

  • Questions and comments 

    855-700-0660

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    AUEBLISS 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73143-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    SQUALANE (UNII: GW89575KF9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALLANTOIN (UNII: 344S277G0Z)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    2-HYDROXYETHYL ACRYLATE (UNII: 25GT92NY0C)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TRICAPRIN (UNII: O1PB8EU98M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73143-002-0156 g in 1 TUBE; Type 0: Not a Combination Product01/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/05/2023
    Labeler - Jag Alliance, LLC (081456767)