SANIVIR HANDS, BODY, AND SURFACES SANITIZER- didecyldimonium chloride and benzalkonium chloride liquid liquid
SANIVIR GEL PLUS HAND SANITIZER- didecyldimonium chloride and benzalkonium chloride liquid gel
Kemix Quimica, 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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SANIVIR Sanitizer

SANIVIR Certificate of Analysis

SANIVIR Hands - Data Sheet

SANIVIR Hands, Body and Surfaces - DATA SHEET

SANIVIR Gel Plus - Data Sheet

SANIVIR Gel Plus - DATA SHEET

SANIVIR DOSAGE AND ADMINISTRATION SECTION

WARNINGS

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

INDICATIONS AND USAGE

INDICATIONS AND USAGE SECTION

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN SECTION

PURPOSE

OTC - PURPOSE SECTION

ACTIVE INGREDIENT

SANIVIR Hands, Body, and Surfaces Sanitizer 1,000 Lt (264 gallons)

SANIVIR 1000 77396-001-01

SANIVIR Hands, Body, and Surfaces Sanitizer 5Lt (1.32 gallons)

SANIVIR 5 77396-001-02

SANIVIR Hands, Body, and Surfaces Sanitizer 75ml (2.4fl.oz)

SANIVIR 75 NDC: 77396-01-003

SANIVIR Gel Plus Sanitizer 75ml (2.4fl.oz)

SANIVIR Gel Plus 75 NDC: 77396-002-02

SANIVIR Gel Plus Sanitizer 5Lt (1.32gal)

SANIVIR Gel Plus 5 NDC: 77396-002-01

SANIVIR HANDS, BODY, AND SURFACES SANITIZER
didecyldimonium chloride and benzalkonium chloride liquid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77396-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA)	DIDECYLDIMONIUM CHLORIDE	2.5 mg in 0.001 L
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg in 0.001 L

Ingredient Name	Strength
Inactive Ingredients
TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE) (UNII: 36YHT392ID)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77396-001-01	1000 L in 1 CONTAINER; Type 0: Not a Combination Product	12/12/2020
2	NDC:77396-001-02	5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/12/2020
3	NDC:77396-001-03	0.075 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/12/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/07/2020

SANIVIR GEL PLUS HAND SANITIZER
didecyldimonium chloride and benzalkonium chloride liquid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77396-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA)	DIDECYLDIMONIUM CHLORIDE	2.5 mg in 0.001 L
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg in 0.001 L

Ingredient Name	Strength
Inactive Ingredients
TROLAMINE (UNII: 9O3K93S3TK)
ALCOHOL (UNII: 3K9958V90M)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
METHYL ALCOHOL (UNII: Y4S76JWI15)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77396-002-02	0.075 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/13/2020
2	NDC:77396-002-01	5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/13/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/13/2020

Labeler - Kemix Quimica, S.A. de C.V. (813182128)

Registrant - VR Internatioanl LLC (074181935)

Name	Address	ID/FEI	Business Operations
Establishment
Kemix Quimica, S.A. de C.V.		813182128	manufacture(77396-001, 77396-002)