FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Dhaliwal Laboratories, LLC | Dhaliwal Laboratories,LLC
Effective date
2020-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:35:55

Label at a glance#

ProductHand Sanitizer Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Dosage and administration

Directions wet hands thoroughly with product briskly rub hands together until dry children under 6 years of age should be supervised when using this product

Storage and handling

store at 20 °C to 25 °C (68°F to 77°F) when possible. Do not store above 40 °C (104° F). may discolor certain fabrics

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredientPurpose
Ethyl Alcohol 70%Antiseptic

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua)

Aloe Barbadensis Leaf Juice (Stabilized* Aloe Vera Gel)

Isopropyl Alcohol

Glycerin

Tetrahydroxypropyl Ethylenediamine

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Tocopheryl Acetate
Isopropyl Myristate.

Purpose Section

OTC - PURPOSE SECTION

Uses

• Hand sanitizer to help decrease bacteria on the skin.

• When water, soap & towel are not available.

• Recommended for repeated use.

Warnings

WARNINGS SECTION

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Indications & Usage

INDICATIONS & USAGE SECTION

When using this product, avoid contact with eyes.

In case of contact flush eyes with water.

Do not apply around eyes. Do not use in ears & mouth.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Children must be supervised in use of this product.

Dosage & Administration Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • wet hands thoroughly with product
  • briskly rub hands together until dry
  • children under 6 years of age should be supervised when using this product

Other information

STORAGE AND HANDLING SECTION

  • store at 20 °C to 25 °C (68°F to 77°F) when possible. Do not store above 40 °C (104° F).
  • may discolor certain fabrics

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

page0001page0001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46432-121-012022-01-28C16284748780-1d6a99b39-9b24-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46432-121-01Hand SanitizerHand Sanitizer60 g in 1 BOTTLEGEL602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46432-121HAND SANITIZER HAND SANITIZER (ALCOHOL) GEL [DHALIWAL LABORATORIES, LLC]2Legacy NDC, 1 package rows20201227_a57ef74d-8ef1-8929-e053-2a95a90a974e.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46432-12146432-121-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
ISOPROPYL ALCOHOLND2M416302IACT
CYMBOPOGON CITRATUS LEAF06JMS448M5IACT
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALCOHOL3K9958V90MACTIB
EDETOLQ4R969U9FRIACT

Source Document#

Source XML · Source PDF

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
b76aca41-37d1-6644-e053-2a95a90a8a1ca57ef74d-8ef1-8929-e053-2a95a90a974e2020-12-26WarningsExact identifier
spl id: b76aca41-37d1-6644-e053-2a95a90a8a1c
spl set id: a57ef74d-8ef1-8929-e053-2a95a90a974e

Reported adverse events (FAERS/openFDA)#

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