SINBIO SANITIZER S-300- didecyldimonium chloride and benzalkonium chloride liquid liquid 
SINBIO, 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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DOSAGE & ADMINISTRATION SECTION

Dosage and Administration Section79370-001-01

INACTIVE INGREDIENT SECTION

Inactive Ingredient Section79370-001-01

WARNINGS SECTION

Warnings Section79370-001-01

INDICATIONS & USAGE SECTION

Indications and Usage79370-001-01

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children79370-001-01

OTC - PURPOSE SECTION

OTC - Purpose Section79370-001-01

OTC - ACTIVE INGREDIENT SECTION

OTC - Active Ingredient79370-001-01

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Label S-300 Sanitizer79370-001-01

SINBIO SANITIZER S-300 
didecyldimonium chloride and benzalkonium chloride liquid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79370-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C18) (UNII: 9U1Q4T4ZYS) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C18)0.32 mg  in 0.001 L
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mg  in 0.001 L
Inactive Ingredients
Ingredient NameStrength
OCTYLDIMETHYLAMMONIUM CHLORIDE (UNII: VBX320461J)  
BENZYLDIMETHYLOCTYLAMMONIUM CHLORIDE (UNII: OC19CZY82T)  
WATER (UNII: 059QF0KO0R)  
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79370-001-015 L in 1 CONTAINER; Type 0: Not a Combination Product10/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/09/2020
Labeler - SINBIO, S.A. DE C.V. (951576424)
Registrant - VR INTERNATIONAL LLC (074181935)
Establishment
NameAddressID/FEIBusiness Operations
SINBIO, S.A. DE C.V.951576424pack(79370-001) , manufacture(79370-001) , label(79370-001)

Revised: 6/2020
Document Id: a8888bb5-b933-7073-e053-2a95a90abdee
Set id: a8888bb5-b932-7073-e053-2a95a90abdee
Version: 1
Effective Time: 20200620
 
SINBIO, S.A. DE C.V.