Label at a glance#

ProductIsantizer Hand Sanitizer

Active ingredientALCOHOL

Label structure13 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#

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:

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.
Glycerol (1.45% v/v).
Hydrogen peroxide (0.125% v/v).
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 80% v/v. Purpose: Antiseptic

Alcohol 80% v/v Purpose Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

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

RECENT MAJOR CHANGES SECTION

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

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

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. When Using

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

Directions

DOSAGE & ADMINISTRATION SECTION

DirectionsPlace 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.

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 Childred

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Inactive Ingredients

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Isantizer

Hand Sanitizer

Non Sterile Solution

For External Use Only

Alcohol Antiseptic 80%

Topical Solution

Gallon/3785 mL

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
78013-2112-1	2021-07-23	C162847	48780-1	c7ccaba7-1098-fd44-e053-dadaa90aa01b	a6046e4f-e4ba-8a05-e053-2995a90a4aa1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
78013-2112-1	Isantizer Hand Sanitizer	3785 mL in 1 BOTTLE, PLASTIC	LIQUID	3785		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78013-2112	ISANTIZER HAND SANITIZER LIQUID [ISANTI SPIRITS, LLC]	2	Legacy NDC, 1 package rows	20200527_a6046e4f-e4ba-8a05-e053-2995a90a4aa1.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

Isantizer Hand Sanitizer
HYDROGEN PEROXIDE
ALCOHOL
GLYCEROL FORMAL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
78013-2112	78013-2112-1

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
HYDROGEN PEROXIDE	BBX060AN9V	IACT
ALCOHOL	3K9958V90M	ACTIB
GLYCEROL FORMAL	3L7GR2604E	IACT
WATER	059QF0KO0R	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
a6042ee4-ffa6-6cc1-e053-2a95a90ade17			a6046e4f-e4ba-8a05-e053-2995a90a4aa1	2020-05-19	Warnings	Exact identifier spl id: a6042ee4-ffa6-6cc1-e053-2a95a90ade17 spl set id: a6046e4f-e4ba-8a05-e053-2995a90a4aa1

Reported adverse events (FAERS/openFDA)#

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

Isantizer Hand Sanitizer