Hand Sanitizer

Manufacturer
PakLab
Effective date
2020-11-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:34:32

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Dosage and administration

Wet hand thoroughly with product and rub into skin until dry. Children under 6 years of age should be supervised by an adult when using this product.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

WARNINGS SECTION

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

OTC - WHEN USING SECTION

When using this product avoid contact with face, eyes, and broken skin. If eyes contact occurs, flush thoroughly with water and seek medical advice.

Stop use and ask a doctor if irritation or rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hand thoroughly with product and rub into skin until dry.
  • Children under 6 years of age should be supervised by an adult when using this product.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aqua (water, eau), propylene glycol, glycerin, carbomer, aminomethyl propanol, isopropyl myristate, t-butyl alcohol

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dial pdpdial pdp221 mL NDC: 61531-389-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN1
581660ethanol 0.62 ML/ML Topical GelSCD1
581660ethanol 62 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61531-389-012021-07-23C16284748780-1c7ccaba7-2772-fd44-e053-dadaa90aa01bb57117d9-c7aa-4982-e053-2a95a90a623c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61531-389-01Hand Sanitizer221 mL in 1 BOTTLE, PLASTICGEL2211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61531-389HAND SANITIZER (ALCOHOL) GEL [PAKLAB]1Legacy NDC, 1 package rows20201203_b57117d9-c7aa-4982-e053-2a95a90a623c.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
61531-38961531-389-01

Ingredients#

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

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

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
b55be3f6-ca30-0295-e053-2995a90a6b79b57117d9-c7aa-4982-e053-2a95a90a623c2020-11-30WarningsExact identifier
spl id: b55be3f6-ca30-0295-e053-2995a90a6b79
spl set id: b57117d9-c7aa-4982-e053-2a95a90a623c

Reported adverse events (FAERS/openFDA)#

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