KSS CLEAN HANDS ANTISEPTIC CLEANER (CHLOROXYLENOL) LIQUID [KSS ENTERPRISES]

KSS CLEAN HANDS ANTISEPTIC CLEANER (CHLOROXYLENOL) LIQUID [KSS ENTERPRISES]
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NDC 29991-505-05
Set ID e32ea7f5-028b-4863-92fb-9bb3c469ebc6
Category HUMAN OTC DRUG LABEL
Packager KSS Enterprises
Generic Name
Product Class
Product Number
Application Number PART333
  • 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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