Label: NICE N CLEAN WIPES SANI-HANDS ANTIBACTERIAL HAND WIPES- benzalkonium chloride hand wipes swab

  • NDC Code(s): 44385-7014-1, 44385-7014-2, 44385-7014-3, 44385-7014-4, view more
    44385-7014-5, 44385-7014-6
  • Packager: Nice-Pak Products, Inc.
  • 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 July 19, 2021

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

  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride 0.13%w/w

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use

    To decrease bacteria on the skin

  • WARNINGS

    Warnings

    For external use only.

    Flammable, keep away from fire or flame

    When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or redness develolps and contines for more than 72 hours.

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

    Pull back label slowly.

    Pull out wipe and reseal label.

    Unfold and use, discarding after single use.

    Wet hands thoroughly with product and allow to dry without wiping..

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, SD Alcohol 40-B, Sorbic Acid, PPG-2 Hydroxyethyl Cocamide, Disodium EDTA, Aloe Barbadensis Leaf Juice, Fragrance

  • REFERENCES

    Other information:

    For more information, please visit www.nicencleanwipes.com

  • 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.

  • PRINCIPAL DISPLAY PANEL

    NICE 'N CLEAN WIPES

    SANI-HANDS

    ANTIBACTERIAL HAND WIPES

    HAND ANTIBACTERIAL

    KILLS AND REMOVES 99.9% OF BACTERIA*

    DO NOT FLUSH

    PLASTIC-FREE - 100% PLANT-BASED FIBERS

    *KILLS 99.9% OF THE MOST COMMON BACTERIA

    MANUFACTURED BY: NICE-PAK PRODUCTS, INC. ORANGEBURG, NY 10962

    NICE 'N clean(R) is a registered trademark of Nice-Pak Products, Inc.

    Sani-Hands(R) is a registered trademark of Professional Disposables International, Inc.

    MADE IN USA with domestic and imported materials

    PLASTIC-FREE MADE WITH PLANT-BASED FIBERS

    20 count web:

    20 ct web

    60 count web:

    60 ct web

    80 count (4x20ct) in box

    4x20 tray

    90 count web:

    90 count web

    120 count (6x20ct) tray

    120 count (6x20ct) tray

    320 count (16x20ct) box

    320 count (16x20ct) box

  • INGREDIENTS AND APPEARANCE
    NICE N CLEAN WIPES SANI-HANDS ANTIBACTERIAL HAND WIPES 
    benzalkonium chloride hand wipes swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44385-7014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44385-7014-4261 mL in 1 CELLO PACK; Type 0: Not a Combination Product12/21/2020
    2NDC:44385-7014-2175 mL in 1 CELLO PACK; Type 0: Not a Combination Product12/21/2020
    3NDC:44385-7014-153 mL in 1 CELLO PACK; Type 0: Not a Combination Product12/21/2020
    4NDC:44385-7014-34 in 1 BOX12/21/2020
    4NDC:44385-7014-153 mL in 1 CELLO PACK; Type 0: Not a Combination Product
    5NDC:44385-7014-56 in 1 TRAY12/21/2020
    5NDC:44385-7014-153 mL in 1 CELLO PACK; Type 0: Not a Combination Product
    6NDC:44385-7014-616 in 1 BOX12/21/2020
    6NDC:44385-7014-153 mL in 1 CELLO PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/20/2020
    Labeler - Nice-Pak Products, Inc. (003778198)
    Registrant - Nice-Pak Products, Inc. (003778198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nice-Pak Products, Inc.067900167manufacture(44385-7014)