Label: KSS CLEAN HANDS ANTISEPTIC CLEANER- chloroxylenol liquid

  • 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 August 1, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Chloroxylenol (1% v/v)

  • Purpose

    Antiseptic Hand Cleanser

  • Uses

    • Helps reduce bacteria that potentially can cause disease
    • Helps prevent cross contamination by hand contact
  • Warnings

    • For external use only
    • Do not use near eyes
    • Keep out of reach of children.
    • In case of eye contact flush with water for 15 minutes
    • If irritation persists, get medical attention
    • In case of accidental ingestion, seek medical attention or contact a poison control center immediately.
  • Directions

    • Wet hands and forearms
    • Apply appropriate amount to palm and hand
    • Scrub hands and forearms for 60 seconds
    • Rinse well
    • Wipe dry with towel, repeat if necessary.
  • Other Information

    • Assists with OSHA bloodborne pathogen standard compliance
  • Inactive Ingredients

    Water, Cocoate, Oleate, Cocamidopropyl betaine, Hydroxyethyl Cellulose, Polyquaternium 7, Na4EDTA, 2-Propanol, Peg-75 Lanolin, Aloe Vera Gel, Fragrance, Triclosan, DMDM Hydantoin.

  • Principal Display Panel – Bottle Label

    KSS

    CLEAN HANDS ANTISEPTIC

    Antiseptic Lotion Cleaner

    A Powerful Antiseptic Cleanser for Handwashing Enhanced With Moisturizers

    • Reduces Bacteria on Skin That Can Potentially Cause Disease
    • Assists with OSHA Bloodborne Pathogen Standard Compliance

    See Drug Facts panel for additional information.

    Principal Display Panel – Bottle Label
  • INGREDIENTS AND APPEARANCE
    KSS CLEAN HANDS ANTISEPTIC CLEANER 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29991-505
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    chloroxylenol (UNII: 0F32U78V2Q) (chloroxylenol - UNII:0F32U78V2Q) chloroxylenol10.22 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    potassium oleate (UNII: 74WHF607EU)  
    cocamidopropyl betaine (UNII: 5OCF3O11KX)  
    hydroxyethyl cellulose (2000 CPS at 1%) (UNII: S38J6RZN16)  
    isopropyl alcohol (UNII: ND2M416302)  
    edetate sodium (UNII: MP1J8420LU)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    DMDM hydantoin (UNII: BYR0546TOW)  
    triclosan (UNII: 4NM5039Y5X)  
    potassium cocoate (UNII: F8U72V8ZXP)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29991-505-053785 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33306/01/2007
    Labeler - KSS Enterprises (017173279)
    Establishment
    NameAddressID/FEIBusiness Operations
    Canberra Corporation068080621MANUFACTURE
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