FDA.reportPublic FDA data

Antibacterial Hand Sanitizer

Manufacturer
KLM Promo Products, LLC
Effective date
2021-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:36:43

Label at a glance#

ProductAntibacterial Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

pump as needed on to your palms and thoroughly spread on both hands rub into skin until dry

Storage and handling

store at 20℃(68℉-77℉) may discolor fabrics do not leave under high heat

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Decrease bacteria and germs on the hands
when water, soap, and towel are not available
recommended for repeated use

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

Do not use in ears and mouth

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. In case of contact flush eyes with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops or persists.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children under 6, use only under adult supervision. Not recommended for infants.

Directions

DOSAGE & ADMINISTRATION SECTION

  • pump as needed on to your palms and thoroughly spread on both hands
  • rub into skin until dry

Other information

STORAGE AND HANDLING SECTION

  • store at 20℃(68℉-77℉)
  • may discolor fabrics
  • do not leave under high heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Propylene Glycol, Triethanolamine, Carbomer, Fragrance, Disodium EDTA , Tocopheryl Acetate, Deionized Water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 mL NDC: 77165-350-01

antibacterial hand sanitizer

1 fl.oz. (30ml)

2floz2floz

1floz1floz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
247835ethanol 62 % Topical SolutionPSN2
247835ethanol 0.62 ML/ML Topical SolutionSCD2
247835ethanol 62 % Topical SolutionSY2
247835ethyl alcohol 62 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77165-350-012023-01-30C16284748780-1f386c64a-32ac-0266-e053-dadaa90a7c1aklm hand sanitizer
77165-350-022023-01-30C16284748780-1f386c64a-32ac-0266-e053-dadaa90a7c1aklm hand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77165-350-01Antibacterial Hand Sanitizer30 mL in 1 BOTTLELIQUID302
77165-350-02Antibacterial Hand Sanitizer60 mL in 1 BOTTLELIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77165-350ANTIBACTERIAL HAND SANITIZER (ALCOHOL) LIQUID [KLM PROMO PRODUCTS, LLC]2Legacy NDC, 2 package rows20210111_a6927d27-7058-c5bb-e053-2a95a90aef9f.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77165-35077165-350-01, 77165-350-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
EDETATE DISODIUM7FLD91C86KIACT
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
b878f90e-0fc5-373c-e053-2a95a90a2594a6927d27-7058-c5bb-e053-2a95a90aef9f2021-01-09WarningsExact identifier
spl id: b878f90e-0fc5-373c-e053-2a95a90a2594
spl set id: a6927d27-7058-c5bb-e053-2a95a90aef9f

Reported adverse events (FAERS/openFDA)#

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