Label: HIDOCOMO ANTISEPTIC DISINFECTANT- 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 February 28, 2013

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  • Active ingredient

    CHLOROXYLENOL 3.5%

    Purpose

    antiseptic
  • Use

    For household (laundry,floor,Lavatories),bath,to decrease bacteria on the skin.
  • Warnings

    For external use only. Do not get in eyes,If contact occurs,rinse eyes thoroughly with water

    Keep out of reach of children

    Keep out of reach of children
  • Directions

    Laundry:laundry,linen,napkins,handkerchiefs,etc:3 capfuls to 2.5 litres of water. Floor:Floors,hard surfaces,acrylic materials: 3 capfuls to 2.5 litres of water. Lavatories:Sink,Drains,Bins:Use undiluted BTC antiseptic disinfectant solution. Bath:Add 1 to 2 capfuls to 10 liters of water,take bath normally
  • INACTIVE INGREDIENT

    water,pine oil,polyoxyethylene alkylether,sodium hydroxide,isopropyl alcohol
  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HIDOCOMO ANTISEPTIC DISINFECTANT 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54476-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Propyl alcohol (UNII: 96F264O9SV)  
    .ALPHA.-TERPINEOL (UNII: 21334LVV8W)  
    C12-15 ALCOHOLS (UNII: 2C8M6XLB5C)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Water (UNII: 059QF0KO0R)  
    Caramel (UNII: T9D99G2B1R)  
    C.I. FOOD YELLOW 3 (FREE ACID) (UNII: G2B7JWK1GG)  
    Product Characteristics
    ColororangeScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54476-100-0112 in 1 BOX
    1500 mL in 1 BOTTLE
    2NDC:54476-100-0212 in 1 BOX
    2750 mL in 1 BOTTLE
    3NDC:54476-100-036 in 1 BOX
    32000 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/17/2013
    Labeler - Toma Biotechnology International Corporation-China Division (421300692)
    Registrant - Toma Biotechnology International Corporation-China Division (421300692)
    Establishment
    NameAddressID/FEIBusiness Operations
    Toma Biotechnology International Corporation-China Division421300692manufacture(54476-100)