Label: ARAMARK BURN GEL- lidocaine gel

  • 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 September 9, 2021

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Lidocaine HCL 2.0%

  • Purpose

    Topical pain relief

  • Uses

    Temporary pain relief for minor burns. For

    professional use only.

  • Warnings

    For external use only.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center directly.

    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

    • the condition worsens or symptoms persist for more

    than 7 days or clear up and occur again within a few days

  • 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: do not use, consult a doctor

  • Other Information

    • store at room temperature (do not freeze)

    • do not use any open or torn packets

  • Inactive ingredients

    aloe vera, carbomer, germaben II, menthol,

    propylene glycol, purified water, triethanolamine,

    vitamin E acetate

  • Questions od Comments?

    1-800-456-7077

  • Package Labeling

    aramark

    25 ct. Each Packet Net. Wt. 0.9g

    BURN GEL
    For Temporary Pain Relief of Minor Burns

    aramarkuniform.com

    MANUFACTURED FOR:
    Aramark
    Lenexa, KS 66219 

    886-362-2691

    Please retain carton for drug information.

    5000-5 Burn Gel Box

    5000-5 Burn Gel Pouch

    res

  • INGREDIENTS AND APPEARANCE
    ARAMARK BURN GEL 
    lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81238-5000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    MENTHOL (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81238-5000-525 in 1 BOX05/28/2021
    11 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/28/2021
    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(81238-5000)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!