Label: ARAMARK ANTISEPTIC- benzalkonium chloride, benzocaine 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 May 26, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Benzalkonium Chloride 0.1%

    Benzocaine 5.0%

  • Purpose

    Benzalkonium Chloride ....First aid antiseptic

    Benzocaine .................Total pain relief

  • Uses

    First aid to help prevent infection and for temporary pain

    relief in minor cuts, scrapes and burns

  • Warnings

    For external use only.

    Do not use

    • near eyes or mucous membranes • on deep or

    puncture wounds, animal bites, or serious burns • over large areas

    of the body • more than one week unless directed by a doctor

    Keep out of reach of children.

    If swallowed get medical help or

    contact a Poison Contrl Center right away.

  • Directions

    • clean affected area and spray 1 to 3 times daily

    • may be covered with a sterile bandage • children under 2 ask a

    doctor

  • Inactive ingredients

    isopropyl alcohol, purified water

  • Package Labeling

    aramark

    Cut & Scrape

    Amtiseptic\Spray

    For Temporary Pain
    Relief and to Help
    Prevent Infection in
    Minor Cuts, Scrapes
    and abrasions.

    2 fl. oz. (59.1ml)
    Reorder no. 53000

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

    5300 Antiseptic Spray

    res

  • INGREDIENTS AND APPEARANCE
    ARAMARK ANTISEPTIC 
    benzalkonium chloride, benzocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81238-5300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.0 mg  in 1 mL
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81238-5300-159.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/24/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/24/2021
    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(81238-5300)
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