SEGUCLEAN- alcohol gel 
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.

----------

HAND SANITIZER GEL SEGUCLEAN

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

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)

Revised: 7/2020
Document Id: aaf4f6bc-e3a3-c7cf-e053-2995a90a2dcc
Set id: aa602c11-e2d3-40c1-e053-2a95a90a9875
Version: 3
Effective Time: 20200721
 
Productos y Servicios de Limpieza Seguclean S.A. de C.V.