SEGUCLEAN- alcohol solution 
Productos y Servicios de Limpieza Seguclean S.A. de C.V.

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.

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HAND SANITIZER SOLUTION

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

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)

Revised: 7/2020
Document Id: aaf51c87-3c11-499b-e053-2995a90a6c26
Set id: aaf51c87-3c10-499b-e053-2995a90a6c26
Version: 1
Effective Time: 20200721
 
Productos y Servicios de Limpieza Seguclean S.A. de C.V.