Anti-Bacterial Hand Sanitizer

Manufacturer: Fun Zone, Inc.
Effective date: 2017-02-18
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:48:50

Label at a glance#

ProductAnti-Bacterial Hand Sanitizer

Active ingredientALCOHOL

Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:
Ethyl Alcohol 63%

OTC - PURPOSE SECTION

Purpose:
Antiseptic

WARNINGS SECTION

Warnings:
For external use only. Flammable, keep away from fire, flame and direct sunlight.

OTC - STOP USE SECTION

Stop using this product and consult a doctor If irritation or redness develops.Stop using this product and consult a doctor If irritation or redness develops.

DOSAGE & ADMINISTRATION SECTION

Directions

Rub dime sized amount between hands until dry.
For use by children under 6 years, adult supervision is required.

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Carbomer, Aminomethyl Propanol, Glycerin, Denotonium Benzoate

INDICATIONS & USAGE SECTION

Uses To help reduce bacteria on hands.

OTC - WHEN USING SECTION

When using this product Avoid contact with eyes and lips. If contact occurs, rinse with water.

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 immediately.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1094724	ethanol 63 % Topical Gel	PSN	1
1094724	ethanol 0.63 ML/ML Topical Gel	SCD	1
1094724	ethanol 63 % Topical Gel	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69583-003-00	2023-01-30	C162847	48780-1	f386c64a-3a6f-0266-e053-dadaa90a7c1a	48da4daf-a60a-2c5d-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69583-003-00	Anti-Bacterial Hand Sanitizer	29 mL in 1 BOTTLE, SPRAY	GEL	29		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69583-003	ANTI-BACTERIAL HAND SANITIZER (ETHYL ALCOHOL) GEL [FUN ZONE, INC.]	1	Legacy NDC, 1 package rows	20170219_48da4daf-a60a-2c5d-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Anti-Bacterial Hand Sanitizer
ETHYL ALCOHOL
ALCOHOL
WATER
GLYCERIN
PROPYLENE GLYCOL
CARBOMER INTERPOLYMER TYPE A (55000 CPS)
AMINOMETHYLPROPANOL
DENATONIUM BENZOATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69583-003	69583-003-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALCOHOL	3K9958V90M	ACTIB
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)	59TL3WG5CO	IACT
AMINOMETHYLPROPANOL	LU49E6626Q	IACT
DENATONIUM BENZOATE	4YK5Z54AT2	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
48da4daf-a60b-2c5d-e054-00144ff88e88			48da4daf-a60a-2c5d-e054-00144ff88e88	2017-02-18	Warnings	Exact identifier spl id: 48da4daf-a60b-2c5d-e054-00144ff88e88 spl set id: 48da4daf-a60a-2c5d-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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