Label: READYBATH LUXE- benzalkonium chloride cloth

  • NDC Code(s): 53329-180-76
  • Packager: Medline Industries, LP
  • 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 March 14, 2022

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  • Active ingredient

    Benzalkonium chloride 0.12%

  • Purpose

    Antiseptic

  • Uses

    • for body cleansing to decrease bacteria on the skin
    • helps kill germs that can cause odor
  • Warnings

    For external use only

    Do not use

    • in the eyes

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • irritation and redness develop
    • the condition persists for more than 72 hours or gets worse

    Keep out of reach of children.

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

  • Directions

    • gently pull label tab until package opening is exposed
    • remove cloths one at a time to cleanse body parts in the order of the diagram
    • allow skin to dry
    • dispose of cloth in waste receptacle
    • do not flush cloths in toilet

    diagram

  • Other information

    • avoid excessive heat, protect from freezing
    • washcloth: rayon/polyester
  • Inactive ingredients

    water (aqua), cocamidopropyl PG-dimonium chloride phosphate, glycerin, phenoxyethanol, benzoic acid, dehydroacetic acid, ethylhexylglycerin, disodium EDTA, polysorbate 20, sodium citrate, fragrance, simethicone, aloe barbadensis leaf juice

  • Manufacturing Information

    Manufactured by:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA with domestic and foreign materials

    www.medline.com

    1-800-MEDLINE (633-5463)

    REF: MSC095100

    V1 RK21DYN

  • Package Label

    PDP

  • INGREDIENTS AND APPEARANCE
    READYBATH LUXE 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-180
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-180-76129 g in 1 PACKAGE; Type 0: Not a Combination Product05/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2016
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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