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

SANIVIR Gel Plus Hand Sanitizer by

Drug Labeling and Warnings

SANIVIR Gel Plus Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Kemix Quimica, S.A. de C.V., VR Internatioanl LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANIVIR Certificate of Analysis

USES

WARNINGS

INACTIVE INGREDIENT SECTION

INDICATIONS AND USAGE

KEEP OUT OF REACH OF CHILDREN

PURPOSE

ACTIVE INGREDIENT

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

1000 Lt NDC: 77396-001-01

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

5 Lt NDC: 77396-001-02

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77396-001-01	1000 L in 1 CONTAINER; Type 0: Not a Combination Product	05/07/2020
2	NDC: 77396-001-02	5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/07/2020

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

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

Registrant - VR Internatioanl LLC (074181935)

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