SEGUCLEAN- benzalkonium chloride shampoo 
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.

----------

SANITIZING SHAMPOO

ACTIVE INGREDIENT

BENZALKONIUM CHLORIDE, TRICLOSAN

INACTIVE INGREDIENTS

WATER, GLYCERYN, AROMATIC ESSENCE, COCONUT AMIDE AND SODIUM LAURYL ETHER SULFATE

INDICATIONS AND USAGE

APPLY TO THE PALM OF THE HAND, RUB COVERING BOTH PALMS AND FINGERTIPS, RINSE BOTH HANDS AND ALLOW TO DRY.

DO NOT USE

DO NOT USE IN CHILDREN UNDER TWO MONTHS OF AGE.

DON NOT USE IN EXPOSED WOUNDS

STOP USE

STOP USING THE PRODUCT AND CONSULT A DOCTOR IF IRRITATION OR SKIN RASH APPEARS AND PERSISTS.
THESE CAN BE SIGNS OF A SERIOUS MEDICAL CONDITION.

PURPOSE

PURPOSE ANTIBACTERIAL

KEEP OUT OF THE REACH OF CHILDREN.

KEEP OUT OF THE REACH OF CHILDREN. IN CASE OF INGESTION, SEEK MEDICAL ADVICE IMMEDIATELY OR CONTACT A TOXIC SUBSTANCES CONTROL CENTER.

WARNINGS AND PRECAUTIONS

THE USE OF THIS PRODUCT IN BY CHILDREN UNDER 6 YEARS OLD MUST BE SUPERVISED BY AND OLDER PERSON.

WARNINGS

KEEP OUR OF THE REACH OF CHILDREN

DOSAGE AND ADMINISTRATION

APPLY TO THE PALM OF THE HAND, RUB COVERING BOTH HANDS AND FINGERTIPS, RINSE BOTH HANDS AND ALLOW TO DRY.

PACKAGE LABEL

SHAMPOO SANITIZER 250 mLSHAMPOO SANITIZER 500 mLSHAMPOO SANITIZER 1000 mLSHAMPOO SANITIZER 5000 mL

SEGUCLEAN 
benzalkonium chloride shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79594-4000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.001 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.02 mL  in 1 mL
WATER (UNII: 059QF0KO0R) 0.767 mL  in 1 mL
TRICLOSAN (UNII: 4NM5039Y5X) 0.001 mL  in 1 mL
ROSE OIL (UNII: WUB68Y35M7) 0.003 mL  in 1 mL
SODIUM LAURETH-5 SULFATE (UNII: 410Q7WN1BX) 0.2 mL  in 1 mL
DIETHANOLAMINE (UNII: AZE05TDV2V) 0.005 mL  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.003 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79594-4000-1250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/21/2020
2NDC:79594-4000-2500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/21/2020
3NDC:79594-4000-31000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/21/2020
4NDC:79594-4000-45000 mL in 1 BOTTLE; 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(79594-4000)

Revised: 7/2020
Document Id: aafa0ca8-88c4-2df2-e053-2995a90a0a3a
Set id: aafa0ca8-88c3-2df2-e053-2995a90a0a3a
Version: 1
Effective Time: 20200721
 
Productos y Servicios de Limpieza Seguclean S.A. de C.V.