Label: 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
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Contains inactivated NDC Code(s)
NDC Code(s): 77396-001-01, 77396-001-02, 77396-001-03, 77396-002-01, view more77396-002-02 - Packager: Kemix Quimica, S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 20, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SANIVIR Certificate of Analysis
- DOSAGE & ADMINISTRATION
- 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)
- SANIVIR Hands, Body, and Surfaces Sanitizer 5Lt (1.32 gallons)
- SANIVIR Hands, Body, and Surfaces Sanitizer 75ml (2.4fl.oz)
- SANIVIR Gel Plus Sanitizer 75ml (2.4fl.oz)
- SANIVIR Gel Plus Sanitizer 5Lt (1.32gal)
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INGREDIENTS AND APPEARANCE
SANIVIR HANDS, BODY, AND SURFACES SANITIZER
didecyldimonium chloride and benzalkonium chloride liquid liquidProduct 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 TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE) (UNII: 36YHT392ID) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) 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 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/07/2020 SANIVIR GEL PLUS HAND SANITIZER
didecyldimonium chloride and benzalkonium chloride liquid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77396-002 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 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/13/2020 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, 77396-002)
DOSAGE AND ADMINISTRATION SECTION
KEEP OUT OF REACH OF CHILDREN SECTION
77396-001-02
NDC: 77396-002-02
NDC: 77396-002-01