Label: SEGUCLEAN- alcohol solution

  • 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 July 21, 2020

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  • ACTIVE INGREDIENTS

    Active ingredient Ethyl Alcohol, Benzalkonium Chloride

  • INDICATIONS AND USAGE

    Put enough quantity of product in the palm of the heand, to cover completely. Rub hands vigorously until dry.

    Dilute part of the product with 3 of water and apply with a sprinkler in areas that are clean. Allow to act for 3 to 5 minutes to use the area.

  • DOSAGE AND ADMINISTRATION

    Put enough quantity of product in the palm of the hand to cover the hands. Rub hands vigorously until dry.

  • DO NOT USE

    Do not use in children under two months of age.

    In exposed skin wounds.

  • STOP USE

    Stop using the product avoid contact with the eyes, ears, nose and mouth. In case of contact with the eyes, rinse with plenty of water.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of chindren. In case of ingestion, seek medical advice immediately or contact a Toxic Substances Control Center.

  • WARNINGS AND PRECAUTIONS

    Store at temperatures below 110 degrees F (43 C )

  • WARNINGS

    AVOID FREEZING

    KEEP OUT OF REACH OF CHILDREN

  • PURPOSE

    PURPOSE ANTIMICROBIAL

  • INACTIVE INGREDIENTS

    WATER, GLYCERIN, ESSENCE, COCONUT AMIDE

  • PACKAGE LABEL

    LIQUID SANITIZER 1000 mLLIQUID SANITIZER 5000 mLLIQUID SANITIZER 20000 mL

  • INGREDIENTS AND APPEARANCE
    SEGUCLEAN 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79594-3000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.015 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.2 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIETHANOLAMINE (UNII: AZE05TDV2V) 0.003 mL  in 1 mL
    WATER (UNII: 059QF0KO0R) 0.763 mL  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.015 mL  in 1 mL
    TRICLOSAN (UNII: 4NM5039Y5X) 0.001 mL  in 1 mL
    ROSE OIL (UNII: WUB68Y35M7) 0.003 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79594-3000-11000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/21/2020
    2NDC:79594-3000-25000 mL in 1 JUG; Type 0: Not a Combination Product07/21/2020
    3NDC:79594-3000-320000 mL in 1 JUG; Type 0: Not a Combination Product07/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/21/2020
    Labeler - Productos y Servicios de Limpieza Seguclean S.A. de C.V. (951580477)
    Registrant - Productos y Servicios de Limpieza Seguclean S.A. de C.V. (951580477)
    Establishment
    NameAddressID/FEIBusiness Operations
    Productos y Servicios de Limpieza Seguclean S.A. de C.V.951580477manufacture(79594-3000)
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