Label: SIMPLE HYGIENE ANTIBACTERIAL HAND- chloroxylenol aerosol, foam

  • NDC Code(s): 60933-210-00
  • Packager: FULLER INDUSTRIES, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 28, 2023

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  • Drug Facts

  • Active ingredient

    Chloroxylenol 0.5%

    Purpose

    Antiseptic

  • Uses

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

    For external use only

    Do not use

    in the eyes. In case of contact, flush eyes with water.

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition 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

    • Pump a small amount of foam into palm of hand
    • Rub thoroughly over all surfaces of both hands
    • Rub hands together to produce a thick lather
    • Rinse and repeat
  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Citric Acid, Disodium EDTA, FD&C Blue No. 1, FD&C Yellow No. 5, Fragrance, Isopropanol, Lauramine Oxide, Propylene Glycol, Sodium Olefin Sulfonate, Water

  • Package Labeling:

    Package Label

  • INGREDIENTS AND APPEARANCE
    SIMPLE HYGIENE ANTIBACTERIAL HAND 
    chloroxylenol aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60933-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60933-210-006 in 1 PACKAGE09/01/2017
    11000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)09/01/2017
    Labeler - FULLER INDUSTRIES, INC (078704329)
    Establishment
    NameAddressID/FEIBusiness Operations
    FULLER INDUSTRIES, INC078704329manufacture(60933-210)
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