FDA.reportPublic FDA data

SOBER-SAN

Manufacturer
Rite-Kem Incorporated
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
legacy-cache
Hydrated at
2026-08-01 20:44:53

Label at a glance#

ProductHan-San Topical 80
Active ingredientALCOHOL, BENZALKONIUM CHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70%

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

OTC - DO NOT USE SECTION

  • In children less than 2 months of age
  • on open skin wounds

OTC - STOP USE SECTION

Stop use and ask a doctor if irritiation or rash occurs. These may be signs of serious condition

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

Directions.

  • Place enough product on hands to cover all surfaces. Rub together until dry.
  • Suerpvise children under 6 years of age when using this product to avoid swallowing.

OTHER SAFETY INFORMATION

Other information

store between 15-30 c (59-86F)

Avoid freezing and excessing heat above 40 c (104F)

INACTIVE INGREDIENT SECTION

Inactive ingredients: glycerin, hydrogen peroxide, purified water USP, Ethyl Acrylate, Lavandula Angustifolia Flower, Tocopheryl Acetate, Trolamine.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Han-San Gel 70% alcohol

Fast Acting Effective

Kills 99.9% of Germs and Bacteria on Hands

Made in USA

WWW.RITE-KEM.COM

Sold By

Rite-Kem, Inc.

703 Westmoreland Drive

Tupelo, MS 38801

662-840-6060

NDC: 73943-945-xx

****************************

Han-San Topical 70% alcohol

Alcohol Antiseptic 70%

Topical Solution Hand sanitizer

Non-Sterile Solution

FDA registered

Kills 99.9% of Germs and Bacteria on Hands

Made in USA

WWW.RITE-KEM.COM

Sold By

Rite-Kem, Inc.

703 Westmoreland Drive

Tupelo, MS 38801

662-840-6060

NDC: 73943-946-xx

*******************

Han-San Topical 80% alcohol

Alcohol Antiseptic 80%

Topical Solution Hand sanitizer

Non-Sterile Solution

FDA registered

Kills 99.9% of Germs and Bacteria on Hands

Made in USA

WWW.RITE-KEM.COM

Sold By

Rite-Kem, Inc.

703 Westmoreland Drive

Tupelo, MS 38801

662-840-6060

NDC: 73943-947-xx

*************************

Han-San Gel with Aloe 70% alcohol

Fast Acting Effective

Kills 99.99% of Germs and bacterial on Hands

Made in USA

WWW.RITE-KEM.COM

Sold By

Rite-Kem, Inc.

703 Westmoreland Drive

Tupelo, MS 38801

662-840-6060

NDC: 73943-949-xx

Han San Gel wALOE 55GHan San Gel wALOE 55G

Han San Gel wALOE 2000mlHan San Gel wALOE 2000ml

Han San Gel wALOE 20ozHan San Gel wALOE 20oz

Han San Gel wALOE 12ozHan San Gel wALOE 12oz

Han San Gel wALOE 4ozHan San Gel wALOE 4oz

Han San Gel wALOE 2ozHan San Gel wALOE 2oz

Han San topical 80 16ozHan San topical 80 16oz

Han San topical 80 128ozHan San topical 80 128oz

Han San topical 80 32ozHan San topical 80 32oz

Han San Topical 5GHan San Topical 5G

Han San Topical 275GHan San Topical 275G

Han San Topical 55GHan San Topical 55G

Han San Topical 16ozHan San Topical 16oz

Han San Topical 128ozHan San Topical 128oz

Han San Topical 32ozHan San Topical 32oz

Han San Gel 20ozHan San Gel 20oz

Han San Gel 1.5ozHan San Gel 1.5oz

Han San Gel 2000mlHan San Gel 2000ml

Han San Gel 12ozHan San Gel 12oz

Han San Gel 4ozHan San Gel 4oz

Han San Gel 275GHan San Gel 275G

Han San Gel 55GHan San Gel 55G

Han San Gel 16ozHan San Gel 16oz

Han San Gel 128ozHan San Gel 128oz

Han San Gel 38ozHan San Gel 38oz

Han San Gel 2ozHan San Gel 2oz

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73943-94573943-945-01, 73943-945-02, 73943-945-03, 73943-945-04, 73943-945-05, 73943-945-06, 73943-945-07, 73943-945-08, 73943-945-09, 73943-945-10, 73943-945-11
73943-94673943-946-01, 73943-946-02, 73943-946-03, 73943-946-04, 73943-946-05, 73943-946-06
73943-94773943-947-01, 73943-947-02, 73943-947-03
73943-94973943-949-01, 73943-949-02, 73943-949-03, 73943-949-04, 73943-949-05, 73943-949-06, 73943-949-07
73943-95273943-952-01, 73943-952-02, 73943-952-03, 73943-952-04, 73943-952-05, 73943-952-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
ETHYL ACRYLATE71E6178C9TIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
HYDROGEN PEROXIDEBBX060AN9VIACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALOE VERA WHOLEKIZ4X2EHYXIACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
30e0adee-b8a1-1677-e063-6294a90a5429a1a40588-e4f0-217c-e053-2995a90a0a1f2025-02-12WarningsExact identifier
spl set id: a1a40588-e4f0-217c-e053-2995a90a0a1f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.