Label: CUT CLEANER- benzalkonium chloride, benzocaine cloth

  • 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.

  • Drug Facts

    Active Ingredients

    Benzalkonium Chloride 0.1%

    Benzocaine 5.0%

  • Purpose

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

    Benzocaine .......................... Topical Pain Relief

  • Uses:

    First Aid to help prevent infection and for

    temporary relief from minor cuts, scrapes and burns

  • Warnings:

    For external use only.

    Flammable. Keep away from fire or flame

  • 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

    Keep Out Of Reach Of Children:

    If swallowed, get medical help or contact a Poison Control center right away. 1.800.222.1222

  • DOSAGE & ADMINISTRATION

    Directions:

    • clear affected area
    • tear packet open, unfold towelette and apply on area 1 to 3 times daily
    • maybe covered with a sterile bandage
    • children under 2 ask a doctor
  • Inactive Ingredients:

    isopropyl alcohol. purified water

  • Product Label

    Triple Action

    CUT CLEANER
    Antiseptic Wipe

    1 Premoistened Towelett

    • Helps Prevent Infection
    • Temporary Relief From Minor Cuts, Scrapes And Burns
    • Not For Deep Or Puncture Wounds, Burns Or Animal Bites

                               NDC# 81238-4616-1

    aramark The First Choice In First Aid

    Manufactured for aramark   Lenexa, KS 66219  913-269-9611

    LOT:

    CutClnr

    res

  • INGREDIENTS AND APPEARANCE
    CUT CLEANER 
    benzalkonium chloride, benzocaine cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81238-4616
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.45 mg  in 0.45 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE22.5 mg  in 0.45 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81238-4616-10.45 g in 1 PACKET; Type 0: Not a Combination Product04/09/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/09/2021
    Labeler - Western First Aid Safety dba Aramark (043861524)
    Registrant - Western First Aid Safety dba Aramark (043861524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lights Medical Manufacture Co., Ltd.529128649manufacture(81238-4616)