Label: SEGUCLEAN- alcohol gel

  • 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 70% v/v

  • PURPOSE

    Purpose Antmicrobial

  • DOSAGE AND ADMINISTRATION

    Directions

    Place enough product on hands to cover all surfaces. Rub hands together until dry.

  • INDICATIONS AND USAGE

    Use[s]

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • WARNINGS

    Warnings

    For external use only. Flammable. Keep away from heat or flame

  • WARNINGS AND PRECAUTIONS

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Children under 6 years of age should be supervised when using.

  • STOP USE SECTIONS

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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.

  • INACTIVE INGREDIENTS

    Inactive ingredients Water (Aqua), Glycerin, Carbomer, Triethanolamine

  • PACKAGE LABEL

    LABEL 200000 mLHAND SANITIZER GEL 250 mLHAND SANITIZER GEL 500 mLHAND SANITIZER GEL 1000 mLHAND SANITIZER GEL 5000 mL

  • INGREDIENTS AND APPEARANCE
    SEGUCLEAN 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79594-2000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.55 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.004 mL  in 1 mL
    WATER (UNII: 059QF0KO0R) 0.436 mL  in 1 mL
    TRIETHANOLAMINE CAPROYL GLUTAMATE (UNII: 0F2FO57253) 0.007 mL  in 1 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.003 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79594-2000-3250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/13/2020
    2NDC:79594-2000-4500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/13/2020
    3NDC:79594-2000-51000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/13/2020
    4NDC:79594-2000-65000 mL in 1 JUG; Type 0: Not a Combination Product07/13/2020
    5NDC:79594-2000-2200000 mL in 1 DRUM; Type 0: Not a Combination Product07/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/13/2020
    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(79594-2000)
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