Label: AMERIWIPES DISINFECTANT WIPES- 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 September 10, 2020

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

  • Drug Facts

  • Active ingredients

    Quaternary ammonium salts 3%, Benzalkonium Chloride 0.4%

  • Purpose

    Antiseptic

  • Use[s]

    Use this product as a convenient way to clean and disinfect your household surfaces.

  • Precautionary Statements

    Causes moderate eye irritation. Avoid contact with skin, eyes, or clothing. Do not store in temperature over 90F

    Keep out of reach of children.

  • SPL UNCLASSIFIED SECTION

    Use Ameriwipes on: Bathroom fixtures, countertops, high touch surfaces, patient monitoring equipment, tables, beside tables, computer keyboards, desks, equipment surfaces, faucets, IV stands, light switches, toys** (** rinse toys with clean, potable water after disinfecting), telephones, toilet bowl surfaces gym and more.

  • Directions

    Wipe hard, nonporous surface with wipe until surface is visibly wet. Use enough wipes to keep surfaces visibly wet for 2 minutes. Allow surface to remain wet for 2 minutes. If surfaces are extremely dirty, clean first with another wipe before disinfecting. Discard used wipe in trash. Do not flush in toilet.

  • Inactive ingredients

    Distilled Water, quaternary ammonium salts, ethoxylated alcohol, fragrance

  • SPL UNCLASSIFIED SECTION

    MEDICAL GRADE

    KILLS 99.9% OF GERMS, COLD AND FLU VIRUSES

    ANTIBACTERIAL FORMULA CLEANS, DEODORIZES & DESINFECTS IN ONE EASY STEP

    12.2 POUNDS

    MADE IN USA

    Manufactured and Packaged by

    ALLURE Chemicals

    9650-A Railroad Drive

    EI Paso Texas 79924

    www.allurechemnicals.com

  • Packaging

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  • INGREDIENTS AND APPEARANCE
    AMERIWIPES DISINFECTANT WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78804-215
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    C20-40 PARETH-3 (UNII: 68103A23TQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78804-215-5675 in 1 BOX06/09/2020
    10.8 g in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:78804-215-55100 in 1 BOX06/09/2020
    20.8 g in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:78804-215-00300 in 1 BOX06/09/2020
    30.8 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/09/2020
    Labeler - Allure Chemicals LP (080442496)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Chemicals LP080442496manufacture(78804-215)