Label: ARAMARK BURN- lidocaine hcl spray

  • NDC Code(s): 81238-5100-3
  • Packager: Western First Aid Safety DBA Aramark
  • 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 June 28, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Lidocaine HCl 2.0%

  • Purpose

    Topical pain relief

  • Uses

    Temporary pain relief for minor burns

  • WARNINGS

    Warnings

    For external use only

    Do not use • in large quantities, particularly over raw

    or blistered areas near eyes, if this happens rinse

    thoroughly with water

    Stop use and ask a doctor if condition worsens or

    continues for more than 7 days or clears up and returns

    Keep out of reach of children. If swallowed get

    medical help or contact Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directionsfor adults and children 2 years of age

    and older: spray an even layer of burn spray over

    cleaned affected area not more than 3-4 times daily
    • for children under 2 years of age consult a physician

  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe vera, germaben II, propylene glycol, purified water

  • PRINCIPAL DISPLAY PANEL – 3 oz. bottle

    aramark

    First Aid
    Burn Spray

    For Temporary Pain
    Relief and
    Minor Burns

    4 fl. oz. (118 mL)

    Reorder no. 50004ARA

    MANUFACTURED FOR:
    Aramark
    Lenexa, KS 66219 886-362-2691

    5100 Burn Spray

    res

  • INGREDIENTS AND APPEARANCE
    ARAMARK BURN 
    lidocaine hcl spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81238-5100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81238-5100-3118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/15/2021
    Labeler - Western First Aid Safety DBA Aramark (043861524)
    Registrant - Western First Aid Safety DBA Aramark (043861524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(81238-5100)