Label: ANTIBACTERIAL- chloroxylenol liquid

  • NDC Code(s): 58575-508-01, 58575-508-02
  • Packager: Inopak, Ltd
  • 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 May 4, 2019

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Chloroxylenol 0.3%

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  • Purpose

    Antibacterial

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  • Use

    Handwash to help reduce bacteria on the skin that can potentially cause disease.

    Recommended for repeatd use.

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  • Warnings

    For external use only

    Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation 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..

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  • When using

    Do not get into eyes. In case of eye contact, flush eyes with water.

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  • Stop Use

    • Stop use and ask a doctor if irritation or redness develop or if condition persists for more than 72 hours.
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  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • Wet hands with water and dispense sufficient amount of product into cupped palm of hand.
    • Wash both hands thoroughly for 15 minutes.
    • Rinse under running water and dry thoroughly.
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  • Inactive ingredients

    Citric Acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, Fragrance, Isopropyl Alcohol, Phenoxyethanol, FD&C Red No. 4, Sodium Laureth Sulfate, Water.

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  • Individual label

    Rev 1.0                                                 A FAMILY COMPANY SINCE 1967               800.626.7835

    Part#: 5063-Bortek                                                                                                          sweeperland.com

    Bortek®

                                                    INDUSTRIES, INC.

    FOAMING HAND SOAP

    Antibacterial Hand Wash with Moisturizers

    YOUR CLEANING SOLUTIONS RESOURCE

    Drug Facts

    Active Ingredient                                         Purpose

    Parachlorometaxylenol 0.3% w/w           Antiseptic

    Uses

    • Handwash to help reduce bacteria on the skin that potentially can cause disease.
    • Recommended for repeated use.

    Warnings

    • For external use only
    • Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.
    • Stop use and ask a doctor if irritation or redness develop or if 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

    • Wet hands with water and dispense sufficient amount of product into cupped palm of hand.
    • Wash both hands thoroughly for 15 minutes.
    • Rinse under running water and dry thoroughly.

    Inactive ingredients

    Citric acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, D&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, Water.

    Questions? Call 800-626-7835 or visit our website sweeperland.com

    Reorder Item #28130103                               Net Contents: 1000 ml

    Bortek Individual Label

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  • Multi-pack label

    Rev 1.0                                                 A FAMILY COMPANY SINCE 1967               800.626.7835

    Part#: 5063-BortekCS                                                                                                     sweeperland.com

    Bortek®

    INDUSTRIES, INC.

    FOAMING HAND SOAP

    Antibacterial Hand Wash with Moisturizers          MADE IN THE USA

    YOUR CLEANING SOLUTIONS RESOURCE

    Corporate Headquarters

    4713 Gettysburg Road

    Mechanicsburg, PA 17055

    EQUIPMENT       PARTS   RENTALS              SERVICE               SUPPLIES

    Drug Facts

    Active Ingredient                                         Purpose

    Parachlorometaxylenol 0.3% w/w           Antiseptic

    Uses

    • Handwash to help reduce bacteria on the skin that potentially can cause disease.
    • Recommended for repeated use.

    Warnings

    • For external use only
    • Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.
    • Stop use and ask a doctor if irritation or redness develop or if 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

    Wet hands with water and dispense sufficient amount of product into cupped palm of hand.

    Wash both hands thoroughly for 15 minutes.

    Rinse under running water and dry thoroughly.

    Inactive ingredients

    Citric acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, D&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, Water.

    Questions? Call 800-626-7835 or visit our website sweeperland.com

    Reorder Item #28130103                               Net Contents: 6 x 1000 ml            ANTIBACTERIAL

    Multiple pack label

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  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    chloroxylenol liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58575-508
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Alcohol (UNII: 3K9958V90M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58575-508-01 1000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 01/01/2018
    2 NDC:58575-508-02 4000 mL in 1 CASE; Type 0: Not a Combination Product 01/01/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 01/01/2018
    Labeler - Inopak, Ltd (194718243)
    Establishment
    Name Address ID/FEI Business Operations
    Inopak, Ltd 194718243 manufacture(58575-508)
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