Hand Sanitizer

Manufacturer: Brands International
Effective date: 2020-06-09
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:16:47

Label at a glance#

ProductHand Sanitizer

Active ingredientALCOHOL

Label structure10 sections

Indications and uses

instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease instant hand antiseptic to decrease bacteria on the skin recommended for repeated use

Dosage and administration

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry. Supervise children in the use of this product.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol, 65% w/w

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

instant hand antiseptic to decrease bacteria on the skin
recommended for repeated use

Warnings

WARNINGS SECTION

For external use only. Flammable, keep away from fire or flame.

OTC - WHEN USING SECTION

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if significant irritation or sensitization develops.

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

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

Supervise children in the use of this product.

Other Information

SPL UNCLASSIFIED SECTION

Store below 43°C (110°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, denatonium benzoate, disodium EDTA, glycerin, PEG-40 castor oil, propylene glycol, water, isopropyl myristate.

Please see label on the container.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SanitzerIMG_1682

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Wall1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
902574	ethanol 65 % Topical Gel	PSN	3
902574	ethanol 0.65 ML/ML Topical Gel	SCD	3
902574	ethyl alcohol 65 % Topical Gel	SY	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50157-504-01	2025-01-30	C162847	48780-1	2cef2736-9f0e-d83d-e063-dadaa90ab31f	Germs Be Gone Hand sanitizers
50157-504-02	2025-01-30	C162847	48780-1	2cef2736-9f0e-d83d-e063-dadaa90ab31f	Germs Be Gone Hand sanitizers
50157-504-03	2025-01-30	C162847	48780-1	2cef2736-9f0e-d83d-e063-dadaa90ab31f	Germs Be Gone Hand sanitizers

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50157-504-01	Hand Sanitizer	946 mL in 1 BOTTLE	GEL	946	3
50157-504-02	Hand Sanitizer	443 mL in 1 BOTTLE	GEL	443	3
50157-504-03	Hand Sanitizer	236 mL in 1 BOTTLE	GEL	236	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50157-504	HAND SANITIZER (ALCOHOL) GEL [BRANDS INTERNATIONAL]	3	Legacy NDC, 3 package rows	20200610_6b09fe1f-6b99-4fd4-8fa6-a8144f448838.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Hand Sanitizer
Alcohol
ISOPROPYL MYRISTATE
WATER
PROPYLENE GLYCOL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
GLYCERIN
ALOE VERA LEAF
AMINOMETHYLPROPANOL
PEG-40 CASTOR OIL
EDETATE DISODIUM
DENATONIUM BENZOATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50157-504	50157-504-01, 50157-504-02, 50157-504-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
WATER	059QF0KO0R	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)	59TL3WG5CO	IACT
GLYCERIN	PDC6A3C0OX	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
AMINOMETHYLPROPANOL	LU49E6626Q	IACT
PEG-40 CASTOR OIL	4ERD2076EF	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
DENATONIUM BENZOATE	4YK5Z54AT2	IACT
ALCOHOL	3K9958V90M	ACTIB

Source Document#

Source XML · Source PDF

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
a7aefeca-b4a1-63ae-e053-2995a90a23d3			6b09fe1f-6b99-4fd4-8fa6-a8144f448838	2020-06-09	Warnings	Exact identifier spl id: a7aefeca-b4a1-63ae-e053-2995a90a23d3 spl set id: 6b09fe1f-6b99-4fd4-8fa6-a8144f448838

Reported adverse events (FAERS/openFDA)#

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