FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
LaMotte Chemical Products Company
Effective date
2020-12-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:34:42

Label at a glance#

ProductHand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure12 sections

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

active ingredientactive ingredient

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

inactive ingredientsinactive ingredients

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Hand sanitizerHand sanitizer

Warnings

WARNINGS SECTION

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

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

Do not use

OTC - DO NOT USE SECTION

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

do not usedo not use

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.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

When using this productWhen using this product

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

stop using and ask doctorstop using and ask doctor

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.

keep out of reach of childrenkeep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.
  • directionsdirections

Other information

STORAGE AND HANDLING SECTION

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

Use

INDICATIONS & USAGE SECTION

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

UseUse

Package Label - Principal Display Panel - front

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

236 ml NDC: 22533-375-08

Primary display panelPrimary display panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039900isopropyl alcohol 75 % Topical SolutionPSN3
1039900isopropyl alcohol 0.75 ML/ML Topical SolutionSCD3
1039900isopropyl alcohol 75 % Topical SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
22533-375-082022-01-28C16284748780-1d6a99b39-cd5c-a426-e053-dadaa90af4c2a212e835-ebad-f29f-e053-2995a90a95c0
22533-375-322022-01-28C16284748780-1d6a99b39-cd5c-a426-e053-dadaa90af4c2a212e835-ebad-f29f-e053-2995a90a95c0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
22533-375-08Hand Sanitizer236 mL in 1 BOTTLELIQUID2363
22533-375-32Hand Sanitizer946 mL in 1 BOTTLELIQUID9463

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
22533-375HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [LAMOTTE CHEMICAL PRODUCTS COMPANY]3Legacy NDC, 2 package rows20201208_a212e835-ebad-f29f-e053-2995a90a95c0.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
22533-37522533-375-08, 22533-375-32

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
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
b5e05016-6f8e-27ab-e053-2a95a90af2fda212e835-ebad-f29f-e053-2995a90a95c02020-12-07WarningsExact identifier
spl id: b5e05016-6f8e-27ab-e053-2a95a90af2fd
spl set id: a212e835-ebad-f29f-e053-2995a90a95c0

Reported adverse events (FAERS/openFDA)#

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