FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
RACK Furniture Group for Children, LLC.
Effective date
2020-03-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:28:30

Label at a glance#

ProductHand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

Dosage and administration

Briskly rub generous amount on hands and rub together until dry.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70% v/v. Purpose: Antimicrobial

Purpose

OTC - PURPOSE SECTION

Antimicrobial, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin. Good for repeated use.

Warnings

WARNINGS SECTION

External use only. Keep out of reach of children. Flammable.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Briskly rub generous amount on hands and rub together until dry.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, distilled

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59.2mL NDC: 80428-109-01

2 OZ Bottle2 OZ Bottle

118.3mL NDC: 80428-209-02

4 OZ Bottle4 OZ Bottle

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80428-109-012024-01-30C16284748780-11030e365-08d3-111a-e063-dadaa90a10e2ae8202ce-ddb0-8e41-e053-2a95a90a8a79
80428-209-022024-01-30C16284748780-11030e365-08d3-111a-e063-dadaa90a10e2ae8202ce-ddb0-8e41-e053-2a95a90a8a79

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80428-109-01Hand Sanitizer59.2 in 1 BOTTLELIQUID59.21
80428-209-02Hand Sanitizer118.3 in 1 BOTTLELIQUID118.31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80428-109HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [RACK FURNITURE GROUP FOR CHILDREN, LLC.]1Legacy NDC, 1 package rows20200905_ae8202ce-ddb0-8e41-e053-2a95a90a8a79.zip
80428-209HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [RACK FURNITURE GROUP FOR CHILDREN, LLC.]1Legacy NDC, 1 package rows20200905_ae8202ce-ddb0-8e41-e053-2a95a90a8a79.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80428-10980428-109-01
80428-20980428-209-02

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
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
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
ae8202ce-dda2-8e41-e053-2a95a90a8a79ae8202ce-ddb0-8e41-e053-2a95a90a8a792020-03-30WarningsExact identifier
spl id: ae8202ce-dda2-8e41-e053-2a95a90a8a79
spl set id: ae8202ce-ddb0-8e41-e053-2a95a90a8a79

Reported adverse events (FAERS/openFDA)#

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