AQUALABS ANTISEPTIC HAND SANITIZER GEL

Manufacturer: Aquatonale FZC
Effective date: 2024-12-09
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 00:42:03

Label at a glance#

ProductAQUALABS ANTISEPTIC HAND SANITIZER

Active ingredientALCOHOL

Label structure10 sections

Indications and uses

• hand sanitizer to decrease bacteria on the skin • recommended for repeated use • for use when soap and water are not available

Dosage and administration

• wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing

Storage and handling

• store between 15-30°C (59-86°F) • avoid freezing and excessive heat above 40°C (104°F)

Contacts and useful links#

Websitewww.aq-private-label.com

www.aq-private-label.com

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 72% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

• hand sanitizer to decrease bacteria on the skin

• recommended for repeated use

• for use when soap and water are not available

Warnings

WARNINGS SECTION

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

Do not use

• in children less than 2 months of age

• on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

• irritation and redness develop

• condition persists for more than 72 hours

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

• wet hands thoroughly with product and allow to dry without wiping

• supervise children under 6 years of age when using this product to avoid swallowing

Other information

STORAGE AND HANDLING SECTION

• store between 15-30°C (59-86°F)

• avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, carbomer, fragrance, triethanolamine, tocopheryl acetate.

Questions?

OTC - QUESTIONS SECTION

+ 971 6 557 1415

You may also report serious side effects to this phone number.

Sat-Thur 9:00 AM - 6:00 PM

SPL UNCLASSIFIED SECTION

KILLS 99.9% OF GERMS

With Moisturizers & Vitamin E

MADE IN U.A.E.

www.aq-private-label.com

sales@aquatonale.ae

sales@aquatonale-fze.com

AQUATONALE GROUP

Imitation of Graphics/Pack Design is a punishable offence.

Manufactured by:

Aquatonale FZC, P6-38, SAIF Zone, Sharjah.

United Arab Emirates

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitled

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2277550	ethanol 72 % Topical Gel	PSN	3
2277550	ethanol 0.72 ML/ML Topical Gel	SCD	3
2277550	ethanol 72 % Topical Gel	SY	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
80953-894-10	2026-01-29	C162847	48780-1	d6a99b39-7fdf-a426-e053-dadaa90af4c2	AQUALABS ANTISEPTIC HAND SANITIZER GEL
80953-894-10	2022-11-16	C162847	48780-1	d6a99b39-7fdf-a426-e053-dadaa90af4c2	AQUALABS ANTISEPTIC HAND SANITIZER GEL
80953-894-10	2022-01-28	C162847	48780-1	d6a99b39-7fdf-a426-e053-dadaa90af4c2	AQUALABS ANTISEPTIC HAND SANITIZER GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80953-894-10	AQUALABS ANTISEPTIC HAND SANITIZER	295.7 mL in 1 BOTTLE, PLASTIC	GEL	295.7		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80953-894	AQUALABS ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) GEL [AQUATONALE FZC]	3	Legacy NDC, 1 package rows	20241212_86057011-e944-4683-aaa9-e21711be3cfc.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

AQUALABS ANTISEPTIC HAND SANITIZER
Ethyl Alcohol
ALCOHOL
WATER
GLYCERIN
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
TROLAMINE
.ALPHA.-TOCOPHEROL ACETATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80953-894	80953-894-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALCOHOL	3K9958V90M	ACTIB
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE	0A5MM307FC	IACT
TROLAMINE	9O3K93S3TK	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	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
236728f5-34c8-43f9-9120-ea6e6764f683			86057011-e944-4683-aaa9-e21711be3cfc	2024-12-09	Warnings	Exact identifier spl id: 236728f5-34c8-43f9-9120-ea6e6764f683 spl set id: 86057011-e944-4683-aaa9-e21711be3cfc

Reported adverse events (FAERS/openFDA)#

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