Label at a glance#

ProductHand Sanitizer

Active ingredientBENZALKONIUM CHLORIDE

Label structure12 sections

Dosage and administration

Directions. Apply a small amount of gel to the hands and massage. Wait for it to dry. The exposure time is 15-30 seconds. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 41-80F (5-27C). Avoid freezing and excessive heat above 104F (40C).

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

benzalkonium chloride 0.20%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

Use(s). Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use: 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

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 Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions. Apply a small amount of gel to the hands and massage. Wait for it to dry. The exposure time is 15-30 seconds. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage.

STORAGE AND HANDLING SECTION

Store between 41-80F (5-27C). Avoid freezing and excessive heat above 104F (40C).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients.Water. glycerin, panthenol, aloe vera, hydroxyethyl cellulose, tetrasodium glutamate diacetate, fragrance, chamomile extract, birch leaf extract, elderberry extract.

Labels (80ml)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kids 80ml label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7a33b18d-631c-4c4b-93de-9cf1faef5f73	Product name	1	20250103

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
78522-101-00	2023-01-30	C162847	48780-1	f386c649-ac20-0266-e053-dadaa90a7c1a	gel for kids, 80ml

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
78522-101-00	Hand Sanitizer	80 mL in 1 BOTTLE	GEL	80		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78522-101	HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [NORTHMED]	1	Legacy NDC, 1 package rows	20210325_bdaefe01-0466-f90c-e053-2995a90a59ca.zip

Products#

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

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

Hand Sanitizer
Benzalkonium Chloride
FRAGRANCE FLORAL ORC0902236
WATER
BENZALKONIUM
TETRASODIUM GLUTAMATE DIACETATE
GLYCERIN
ALOE VERA LEAF
HYDROXYETHYL CELLULOSE, UNSPECIFIED
BIRCH TRITERPENES
PANTHENOL
CHAMOMILE FLOWER OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
78522-101	78522-101-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FRAGRANCE FLORAL ORC0902236	R66Z4YW3X0	IACT
WATER	059QF0KO0R	IACT
BENZALKONIUM CHLORIDE	F5UM2KM3W7	ACTIB
TETRASODIUM GLUTAMATE DIACETATE	5EHL50I4MY	IACT
GLYCERIN	PDC6A3C0OX	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIED	T4V6TWG28D	IACT
BIRCH TRITERPENES	BX09B0RQR0	IACT
PANTHENOL	WV9CM0O67Z	IACT
CHAMOMILE FLOWER OIL	60F80Z61A9	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
bdaefe01-0467-f90c-e053-2995a90a59ca			bdaefe01-0466-f90c-e053-2995a90a59ca	2021-03-16	Warnings	Exact identifier spl id: bdaefe01-0467-f90c-e053-2995a90a59ca spl set id: bdaefe01-0466-f90c-e053-2995a90a59ca

Reported adverse events (FAERS/openFDA)#

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

gel for kids, 80ml