Label at a glance#

Product4 Hands Sanitizer

Active ingredientALCOHOL

Label structure13 sections

Storage and handling

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

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.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentag
a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Toba
b. Glycerol (1.45% v/v).
c. Hydrogen peroxide (0.125% v/v).
d. 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

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Indications & Usage

Warnings

WARNINGS SECTION

For 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

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.

OTC - STOP USE SECTION

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

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.

Dosage & Administration

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.

Other Information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

1 GAL Healthcare Personnel Ethyl Alcohol Hand Sanitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1039339	Ethanol (Topical)	ethanol 0.8 ML/ML Topical Solution	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1039339	ethanol 80 % Topical Solution	PSN	2
1039339	ethanol 0.8 ML/ML Topical Solution	SCD	2
1039339	ethanol 80 % Topical Solution	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73951-0001-1	2021-07-23	C162847	48780-1	c7ccaba7-21ed-fd44-e053-dadaa90aa01b	4 Hands Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73951-0001-1	4 Hands Sanitizer	3785.41 mL in 1 BOTTLE	SOLUTION	3785.41		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73951-0001	4 HANDS SANITIZER (HAND SANITIZER) SOLUTION [4 HANDS BREWING COMPANY, LLC]	2	Legacy NDC, 1 package rows	20200415_a1b18e8c-0ad7-38ac-e053-2a95a90a26af.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

4 Hands Sanitizer
Hand Sanitizer
ALCOHOL
GLYCERIN
WATER
HYDROGEN PEROXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
73951-0001	73951-0001-1

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
Name	UNII	Kind
ALCOHOL	3K9958V90M	ACTIB
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
HYDROGEN PEROXIDE	BBX060AN9V	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a3497488-274b-7b9c-e053-2995a90aa015			a1b18e8c-0ad7-38ac-e053-2a95a90a26af	2020-04-14	Warnings	Exact identifier spl id: a3497488-274b-7b9c-e053-2995a90aa015 spl set id: a1b18e8c-0ad7-38ac-e053-2a95a90a26af

Reported adverse events (FAERS/openFDA)#

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

4 Hands Sanitizer