Label: PAIN RELIEF BODY AUDACIOUS WRECK RELIEF- lidocaine spray

  • 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 17, 2022

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  • Active ingredient                       Purpose

    Lidocaine 4 %                             Topical Anesthetic      

  • PURPOSE

  • Uses

    For temporary relief of pain and itching due to :

    • sunburn
    • scrapes
    • insect bites
    • minor skin irritations
  • WARNINGS

    Warnings
    For external use only

    Flammable: Do not use while smocking or near heat of flame.

  • Do not use

    to wounds or damaged skin • do not use in large quantities, particularly over raw surface or blistered areas.

  • When using this product

    • avoid contact with eyes 
    • use only as directed
    • do not puncture or incinerate
    • content under pressure, do not store at temperature above 120 0F
  • Stop use and ask doctor if

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

    If pregnant or breast-feeding, ask a health professional before use.

  • Keep out of reach of children.

     If accidentally ingested get medical help or contact a Poison Control Center immediately

  • Direction


    • Adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily
    • Children under 2 years old: consult a doctor

  • Inactive ingredients

    Alcohol Denat.
    Aloe Barbadensis Leaf Extract
    Carbomer
    Chamomilla Recutita (Matricaria) Flower Extract
    Cucumis Sativus (Cucumber) Fruit Extract
    Diazolidinyl Urea
    Disodium Cocoamphodipropionate
    Disodium EDTA
    Full Spectrum Industrial Hemp Extract
    Glycerin
    Propylene Glycol
    Simethicone
    Tocopheryl Acetate
    Triethanolamine
    Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF BODY   AUDACIOUS WRECK RELIEF
    lidocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82212-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE (UNII: V5VD430YW9)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    CUCUMBER (UNII: YY7C30VXJT)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CANNABIS SATIVA WHOLE (UNII: B5ONF538PB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82212-001-03142 g in 1 CAN; Type 0: Not a Combination Product11/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/08/2021
    Labeler - Australis Capital (Nevada) Inc. (081483723)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions LLC081030372manufacture(82212-001)
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