FDA.reportPublic FDA data

Kern Sani Hand Sanitizer

Manufacturer
KERN SANI, INC.
Effective date
2021-11-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:44:48

Label at a glance#

ProductKern Sani Hand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient[s]

Alcohol 70%

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Use[s]

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

WARNINGS SECTION

Warnings

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

OTC - DO NOT USE SECTION

Do not use

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

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a 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 hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

OTHER SAFETY INFORMATION

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Principal Display Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​DISTRIBUTED BY

KERN SANI, INC.

5016 CALIFORNIA AVE. - SUITE 3

BAKERSFIELD, CA 93309

HAND SANITIZER

NON-STERILE SOLUTION

ALCOHOL ANTISEPTIC 70%

TOPICAL SOLUTION

4 OUNCES (118 ML)

KS 4 OzKS 4 Oz

8 OZ

KS 8 OzKS 8 Oz

16 OZ

KS 16 OzKS 16 Oz

32 OZ

KS 32 OzKS 32 Oz

1 Gal

KS 1 GalKS 1 Gal

5 Gal

KS 5 GalKS 5 Gal

50 Gal

KS 50 GalKS 50 Gal

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN3
582753ethanol 0.7 ML/ML Topical SolutionSCD3
582753ethanol 70 % Topical SolutionSY3
582753ethyl alcohol 70 % Topical SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77804-001-012023-01-30C16284748780-1f386c649-dc5f-0266-e053-dadaa90a7c1aebf0d903-6796-4716-8bd9-d33d4db8b8d0
77804-001-022023-01-30C16284748780-1f386c649-dc5f-0266-e053-dadaa90a7c1aebf0d903-6796-4716-8bd9-d33d4db8b8d0
77804-001-032023-01-30C16284748780-1f386c649-dc5f-0266-e053-dadaa90a7c1aebf0d903-6796-4716-8bd9-d33d4db8b8d0
77804-001-042023-01-30C16284748780-1f386c649-dc5f-0266-e053-dadaa90a7c1aebf0d903-6796-4716-8bd9-d33d4db8b8d0
77804-001-112023-01-30C16284748780-1f386c649-dc5f-0266-e053-dadaa90a7c1aebf0d903-6796-4716-8bd9-d33d4db8b8d0
77804-001-122023-01-30C16284748780-1f386c649-dc5f-0266-e053-dadaa90a7c1aebf0d903-6796-4716-8bd9-d33d4db8b8d0
77804-001-132023-01-30C16284748780-1f386c649-dc5f-0266-e053-dadaa90a7c1aebf0d903-6796-4716-8bd9-d33d4db8b8d0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77804-001-01Kern Sani Hand Sanitizer118 mL in 1 BOTTLE, PUMPSOLUTION1183
77804-001-02Kern Sani Hand Sanitizer236 mL in 1 BOTTLE, PUMPSOLUTION2363
77804-001-03Kern Sani Hand Sanitizer473 mL in 1 BOTTLE, PUMPSOLUTION4733
77804-001-04Kern Sani Hand Sanitizer946 mL in 1 BOTTLE, PUMPSOLUTION9463
77804-001-11Kern Sani Hand Sanitizer3786 mL in 1 BOTTLE, PUMPSOLUTION37863
77804-001-12Kern Sani Hand Sanitizer18928 mL in 1 JUGSOLUTION189283
77804-001-13Kern Sani Hand Sanitizer189270 mL in 1 DRUMSOLUTION1892703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77804-001KERN SANI HAND SANITIZER (ALCOHOL) SOLUTION [KERN SANI, INC.]3Legacy NDC, 7 package rows20211106_ebf0d903-6796-4716-8bd9-d33d4db8b8d0.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77804-00177804-001-01, 77804-001-02, 77804-001-03, 77804-001-04, 77804-001-11, 77804-001-12, 77804-001-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT

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
8eb36da6-0b15-410f-b59a-f38064f6f019ebf0d903-6796-4716-8bd9-d33d4db8b8d02021-11-05WarningsExact identifier
spl id: 8eb36da6-0b15-410f-b59a-f38064f6f019
spl set id: ebf0d903-6796-4716-8bd9-d33d4db8b8d0

Reported adverse events (FAERS/openFDA)#

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