FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
HS HomeWorx LLC | Cosbe Laboratory Inc
Effective date
2021-05-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:44

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Spray on hands thoroughly and rub until dry

Storage and handling

Do not store above 110F (43C) May discolor certain fabrics and surfaces

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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (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

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

to help reduce bacteria on skin

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from fire, flame and high heat.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Avoid contact with broken skin. Do not inhale or ingest.

OTC - STOP USE SECTION

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

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

  • Spray on hands thoroughly and rub until dry

Other information

STORAGE AND HANDLING SECTION

  • Do not store above 110F (43C)
  • May discolor certain fabrics and surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Butylene Glycol, Fragrance (Parfum), Aloe Barbadensis Leaf Extract, Artemisia Argyi Leaf Extract, Cnidium Monnieri Fruit Extract, Sargassum Fusiforme Extract

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

56 mL NDC: 81282-051-01

56 mL PS56 mL PS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2286295ethanol 75 % Topical SprayPSN1
2286295ethanol 0.75 ML/ML Topical SpraySCD1
2286295ethanol 75 % Topical SpraySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81282-051-012023-01-30C16284748780-1f386c64a-2d2f-0266-e053-dadaa90a7c1ac29fc724-3eb4-5e3c-e053-2995a90af679

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81282-051-01Hand Sanitizer56 mL in 1 BOTTLE, SPRAYSPRAY561

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81282-051HAND SANITIZER (ALCOHOL) SPRAY [HS HOMEWORX LLC]1Legacy NDC, 1 package rows20210801_c29fc724-3eb4-5e3c-e053-2995a90af679.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
81282-05181282-051-01

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
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT

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
c29fc724-3ea5-5e3c-e053-2995a90af679c29fc724-3eb4-5e3c-e053-2995a90af6792021-05-18WarningsExact identifier
spl id: c29fc724-3ea5-5e3c-e053-2995a90af679
spl set id: c29fc724-3eb4-5e3c-e053-2995a90af679

Reported adverse events (FAERS/openFDA)#

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