Label: SIMPLY DONE- benzalkonium chloride 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 October 18, 2018

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

View All Sections
  • Active Ingredient

    Benzalkonium Chloride 0.115%

  • Purpose

    Antibacterial

  • Uses

    For handwashing to decrease bacteria on the skin

  • Warnings

    For external use only

  • Do not use

    • in the eyes
    • if you are allergic to any of the ingredients
  • When using this product

    if eye contact occurs, rinse eyes thoroughly with water.

  • Stop use and ask a doctor if

    if irritation and redness develops and persist for more than 72 hours.

  • Keep out of reach of children

    if swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    • Storage, Store at room temperature
    • Dispensing Remove seal band. Lift tab at front of lid. Pull up corner of center sheet and thread through dispenser slit in lid. Close lid to retain moisture.
    • Use. Apply wipe thoroughly to hands as desired. Allow to dry without wiping.
    • Disposal. Dispose of used wipes in a trash receptacle after use. Do not flush.
  • Inactive ingredients

    Water, Aloe Barbadensis Leaf Extract, Disodium Cocoamphodiacetate, SD Alcohol 40-B, Methylchloroisothiazolinone, Methylisothiazolinone, Tocopheryl Acetate, Disodium EDTA, Citric Acid, Fragrance

  • Package Label

    Simply Done Fresh Label

  • INGREDIENTS AND APPEARANCE
    SIMPLY DONE 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-053
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.115 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-053-4040 in 1 CANISTER; Type 0: Not a Combination Product05/27/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/27/2013
    Labeler - Topco Associates, LLC (006935977)
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!