INSTANT HAND SANITIZER – alcohol gel

Manufacturer: Safetec of America | Safetec of America, Inc.
Effective date: 2010-09-15
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:25:51

Label at a glance#

ProductInstant Hand Sanitizer

Active ingredientalcohol

Label structure11 sections

Indications and uses

for handwashing to decrease bacteria on skin without soap and water recommended for repeated use

Dosage and administration

wet hands thoroughly with product allow to dry without wiping children under 6 should be supervised while using this product

Contacts and useful links#

Websitewww.statina.com.au

www.statina.com.au

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Safetec of America, Inc.

Instant Hand Sanitizer

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

for handwashing to decrease bacteria on skin without soap and water
recommended for repeated use

Warnings

WARNINGS SECTION

For external use only

Flammable, keep away from fire or flame

OTC - DO NOT USE SECTION

Do not use in the eyes. If this happens, rinse thoroughly with water

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If ingested get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

wet hands thoroughly with product
allow to dry without wiping
children under 6 should be supervised while using this product

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, carbomer, D&C green #5, D&C yellow#10, fragrance, purified water, triethanolamine

Supplied by

STATINA

HEALTHCARE AUSTRALIA

3/12 Yatala Rd.

Mt. Kuring-Gai, NSW, 2080

1300 365 404

www.statina.com.au

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-4111-0

Safetec

instant

Hand

Sanitizer

Kills 99.9% of Germs

Enriched with

Aloe Vera

Fresh

16 FL. OZ. (473 ML)

Reorder No. 17358

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
581662	ethanol 70 % Topical Gel	PSN	1
581662	ethanol 0.7 ML/ML Topical Gel	SCD	1
581662	ethanol 70 % Topical Gel	SY	1
581662	ethyl alcohol 70 % Topical Gel	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61010-4111-0	2020-01-31	C162847	48780-1	9d75b9d0-5017-f424-e053-dadaa90a57ce	INSTANT HAND SANITIZER – alcohol gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61010-4111-0	Instant Hand Sanitizer	473 mL in 1 BOTTLE, PUMP	GEL	473		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61010-4111	INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA]	1	Current NDC, Legacy NDC, 1 package rows	20100921_3784c55f-928f-4766-902a-d09ba1ed42ae.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
alcohol	ACTIVE INGREDIENT	3K9958V90M	1
alcohol	ACTIVE MOIETY	3K9958V90M	1
aloe	INACTIVE INGREDIENT	V5VD430YW9	1
trolamine	INACTIVE INGREDIENT	9O3K93S3TK	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

Instant Hand Sanitizer
alcohol
aloe
water
trolamine

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61010-4111	61010-4111-0

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
alcohol	3K9958V90M	ACTIB
aloe	V5VD430YW9	IACT
water	059QF0KO0R	IACT
trolamine	9O3K93S3TK	IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
trolamine	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Instant Hand Sanitizer	ALCOHOL	Safetec of America, Inc.	0f6f2a67-4fed-407e-a2c5-51574a5bbf65	2024-03-01	Warnings	Exact identifier ndc (product): 61010-4111
61b46712-2151-4e32-8f25-141c3cbddc04			3784c55f-928f-4766-902a-d09ba1ed42ae	2010-09-15	Warnings	Exact identifier spl id: 61b46712-2151-4e32-8f25-141c3cbddc04 spl set id: 3784c55f-928f-4766-902a-d09ba1ed42ae

Reported adverse events (FAERS/openFDA)#

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