Label: ARAMARK BURN CREAM- lidocaine hydrochloride, benzalkonium chloride 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 May 21, 2021

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient
    Benzalkonium Chloride 0.13%
    Antiseptic Lidocaine HCI0.5%

  • PURPOSE

    Purpose
    Benzalkonium Chloride ......First Aid Antiseptic

    Lidocaine HCl .................Topical Analgesic

  • INDICATIONS & USAGE

    Uses:
    • Temporary relief of pain associated with minor cuts, scrapes,
       and burns
    • Helps protect against harmful bacteria

  • WARNINGS

    Warnings: For External Use Only
    Do not use:
    • in eyes • in large quantities • over raw or blistered areas, or on
    deep puncture wounds,
    animal bites, or serious burns • for more than one week unless
    directed by a doctor

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If ingested, contact a Poison
    Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:
    • clean affected area • apply small amount not more than 3 times
      daily
    • may be covered with a sterile bandage

  • INACTIVE INGREDIENT

    Inactive Ingredients: Peregal-O, Glycerin Monostearate,
    Glycerol, Purified Water

  • Product Package

    aramark

    25 ct. of 1g packets

    FIRST AID/
    BURN CREAM

    ANTISEPTIC•ANESTHETIC

    RELIEVES PAIN • SOOTHES • PROTECTS
    AGAINST INFECTION

    Retain carton for complete product information

    REMOVE TOP FOR
    EASY ACCESS

    ANTISEPTIC•ANESTHETIC

    compares to
    J&J First
    Aid Cream

    RELIEVES PAIN•SOOTHES•
    PROTECTS AGAINST INFECTION

    aramarkuniform.com

    MANUFACTURED BY:
    Aramark
    Lenexa, KS 66219 (913) 269-9611

    4622 25 Ct Box

    res

  • INGREDIENTS AND APPEARANCE
    ARAMARK BURN CREAM 
    lidocaine hydrochloride, benzalkonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81238-4622
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 1 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    DIGLYCERIN MONOSTEARATE (UNII: E3XK1VOF1Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81238-4622-225 in 1 BOX04/23/2021
    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 finalpart34804/23/2021
    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(81238-4622)
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!