Hand Sanitizer

Manufacturer: Below Sea Level
Effective date: 2020-04-15
Label type: HUMAN OTC DRUG LABEL
Version: 604838198
Source: full-release
Hydrated at: 2026-05-31 23:06:30

Label at a glance#

ProductHand Sanitizer

Active ingredientISOPROPYL ALCOHOL

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:

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.
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

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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.

OTC - STOP USE SECTION

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

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

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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

29.57 ml NDC: 75415-320-01

29.57 ml back label29.57 ml front label

118.29 ml NDC: 75415-320-04

118.29 ml front label

118.29 ml back label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1598066	isopropyl alcohol 75 % Topical Spray	PSN	604838198
1598066	isopropyl alcohol 0.75 ML/ML Topical Spray	SCD	604838198
1598066	isopropyl alcohol 75 % Topical Spray	SY	604838198

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
75415-320-01	2021-07-23	C162847	48780-1	c7ccaba7-13ce-fd44-e053-dadaa90aa01b	a35ed79b-ea24-7b96-e053-2a95a90a672a
75415-320-04	2021-07-23	C162847	48780-1	c7ccaba7-13ce-fd44-e053-dadaa90aa01b	a35ed79b-ea24-7b96-e053-2a95a90a672a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
75415-320-01	Hand Sanitizer	29.57 mL in 1 BOTTLE	SPRAY	29.57		604838198
75415-320-04	Hand Sanitizer	118.29 mL in 1 BOTTLE	SPRAY	118.29		604838198

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75415-320	HAND SANITIZER (ISOPROPYL ALCOHOL) SPRAY [BELOW SEA LEVEL]	604838198	Legacy NDC, 2 package rows	20200416_a35ed79b-ea24-7b96-e053-2a95a90a672a.zip

Products#

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

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

Hand Sanitizer
Isopropyl Alcohol
GLYCERIN
HYDROGEN PEROXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
75415-320	75415-320-01, 75415-320-04

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
GLYCERIN	PDC6A3C0OX	IACT
HYDROGEN PEROXIDE	BBX060AN9V	IACT
WATER	059QF0KO0R	IACT
ISOPROPYL ALCOHOL	ND2M416302	ACTIB

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
a35ecb23-05c8-b853-e053-2995a90a2cad			a35ed79b-ea24-7b96-e053-2a95a90a672a	2020-04-15	Warnings	Exact identifier spl id: a35ecb23-05c8-b853-e053-2995a90a2cad spl set id: a35ed79b-ea24-7b96-e053-2a95a90a672a

Reported adverse events (FAERS/openFDA)#

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