Label: BLOOM WELLNESS- benzalkonium chloride patch

  • 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 April 19, 2021

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  • Active ingredients

    Benalkonium chloride 0.115%

  • Purpose

    Antimicrobial

  • Uses

    • For hand sanitizing to decrease bacteria on the skin.
    • Recommended for repeated use.
  • Warnings

    For external use only.

  • Do Not Use

    Do not use over large areas of the body or if you are allergic to any of these ingredients.

  • When using this product 

    Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

  • Stop use and ask a doctor if

    If irritation or redness develops and persists 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:

    • To use, peel back label, pull out wipe and firmly reseal label to maintain package moisture. Do not remove label.
    • Unfold cloth and rub thoroughly over all surfaces of both hands. Use only once and throw away. After cleansing, dispose of wipe in a trash receptacle. Rub hands together briskly to dry.
  • Inactive ingredients

    Water, Behentrimonium Chloride, Dihydroxypropyl Peg-5 Linoleammonium Chloride, Glycereth-2 Cocoate, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate (Vitamin E), Phenoxyethanol, Potassium Sorbate, Fragrance

  • Other Information

    *Kills 99.9% of germs that may cause illness, including E. Coli and MRSA in just 15 seconds.

    Bloom Wellness logo™ and Free Of logo™ are trademarks of U.S. Nonwovens Corp.
    All rights reserved.


    **This product is not manufactured or distributed by Edgewell Personal Care, owner of the registered trademark, Wet Ones®.


    DISTRIBUTED BY: U.S. NONWOVENS CORP. 100 EMJAY BLVD., BRENTWOOD, NY 11717

  • Principal Display Panel

    bloom WELLNESS WIPESTM

    ANTIBACTERIAL HAND WIPES

    FRESH SCENT

    KILLS 99.9% OF GERMS*

    DO NOT FLUSH

    25  Wipes

    7.4 IN x 7.2 IN (18.79cmx18.28 cm)

    Label

  • INGREDIENTS AND APPEARANCE
    BLOOM WELLNESS 
    benzalkonium chloride patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52553-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.115 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)  
    GLYCERETH-2 (UNII: 0UY833L6XU)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52553-005-2525 in 1 PACKAGE03/16/2021
    10.115 mg in 1 PATCH; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/16/2021
    Labeler - Radienz Living, LLC (117451061)
    Registrant - Radienz Living, LLC (080453184)
    Establishment
    NameAddressID/FEIBusiness Operations
    Radienz Living, LLC080453184manufacture(52553-005)
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