FDA.reportPublic FDA data

Kern Sani, Inc Hand Sanitizer - Unscented Gel

Manufacturer
KERN SANI, INC.
Effective date
2021-03-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:15

Label at a glance#

ProductKern Sani, Inc Hand Sanitizer - Unscented Gel
Active ingredientALCOHOL
Label structure13 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient[s]

Alcohol 70%v/v

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 aloe vera extract, carbomer 980 powder,

glycerol, hydrogen peroxide, purified water USP, triethanolamine

Principal Display Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KERN

SANI

       PREMIUM

HAND SANITIZER

UNSCENTED GEL

​NON-STERILE SOLUTION

​ALCOHOL ANTISEPTIC 70%

  8 FL OZ (236 mL)

Manufactured and distributed by Kern Sani Inc.

5016 California Ave. Suite3, Bakersfield, CA 93309

Lot#

Exp.

004-02 8 OZ Unsctd Gel004-02 8 OZ Unsctd Gel

004-03 16OZ Unsctd Gel004-03 16OZ Unsctd Gel

004-04 32OZ Unsctd Gel004-04 32OZ Unsctd Gel

004-11 1Gal Unsctd Gel004-11 1Gal Unsctd Gel

004-12 5Gal Unsctd Gel004-12 5Gal Unsctd Gel

004-13 50Gal Unsctd Gel004-13 50Gal Unsctd Gel

res

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77804-004-022023-01-30C16284748780-1f386c649-e4c8-0266-e053-dadaa90a7c1aKern Sani, Inc Hand Sanitizer - Unscented Gel
77804-004-032023-01-30C16284748780-1f386c649-e4c8-0266-e053-dadaa90a7c1aKern Sani, Inc Hand Sanitizer - Unscented Gel
77804-004-042023-01-30C16284748780-1f386c649-e4c8-0266-e053-dadaa90a7c1aKern Sani, Inc Hand Sanitizer - Unscented Gel
77804-004-112023-01-30C16284748780-1f386c649-e4c8-0266-e053-dadaa90a7c1aKern Sani, Inc Hand Sanitizer - Unscented Gel
77804-004-122023-01-30C16284748780-1f386c649-e4c8-0266-e053-dadaa90a7c1aKern Sani, Inc Hand Sanitizer - Unscented Gel
77804-004-132023-01-30C16284748780-1f386c649-e4c8-0266-e053-dadaa90a7c1aKern Sani, Inc Hand Sanitizer - Unscented Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77804-004-02Kern Sani, Inc Hand Sanitizer - Unscented Gel236 mL in 1 BOTTLE, PLASTICSOLUTION2361
77804-004-03Kern Sani, Inc Hand Sanitizer - Unscented Gel473 mL in 1 BOTTLE, PLASTICSOLUTION4731
77804-004-04Kern Sani, Inc Hand Sanitizer - Unscented Gel946 mL in 1 BOTTLE, PLASTICSOLUTION9461
77804-004-11Kern Sani, Inc Hand Sanitizer - Unscented Gel3785 mL in 1 BOTTLE, PLASTICSOLUTION37851
77804-004-12Kern Sani, Inc Hand Sanitizer - Unscented Gel18925 mL in 1 JUGSOLUTION189251
77804-004-13Kern Sani, Inc Hand Sanitizer - Unscented Gel189250 mL in 1 DRUMSOLUTION1892501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77804-004KERN SANI, INC HAND SANITIZER - UNSCENTED GEL (ALCOHOL) SOLUTION [KERN SANI, INC.]1Legacy NDC, 6 package rows20210327_cac0e2db-980b-4e56-a03e-671a1af76fc8.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77804-00477804-004-02, 77804-004-03, 77804-004-04, 77804-004-11, 77804-004-12, 77804-004-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER 9804Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT

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
65e8302e-75b6-4a17-8902-02ba6ddd5253cac0e2db-980b-4e56-a03e-671a1af76fc82021-03-26WarningsExact identifier
spl id: 65e8302e-75b6-4a17-8902-02ba6ddd5253
spl set id: cac0e2db-980b-4e56-a03e-671a1af76fc8

Reported adverse events (FAERS/openFDA)#

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