Opal, Hand Sanitizer, Gel, 75% Ethyl alcohol, 95mL

Manufacturer: Opal Cosmetics (Huizhou) Limited | A03 Lab of BTS
Effective date: 2020-04-17
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-01 23:35:25

Label at a glance#

ProductAroma Guardian

Active ingredientALCOHOL

Label structure12 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Do not store above 105℉ (40.6℃) May discolor some fabrics Harmful to wood finishes and plastics

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

Flammable. For external use only. Keep away from heat or flame.

Do not use

OTC - DO NOT USE SECTION

on 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.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

Do not store above 105℉ (40.6℃)
May discolor some fabrics
Harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, t-Butyl Alcohol, Aminomethyl Propanol, Aloe Barbadensis Leaf Extract, Maltodextrin, Denatonium Benzoate.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	4891893029751	GTIN-13: 4891893029751 EAN-13: 4891893029751 GTIN storage (14 digits): 04891893029751	95.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42477-2022-1	2022-01-28	C162847	48780-1	d6a99b39-3ada-a426-e053-dadaa90af4c2	Opal, Hand Sanitizer, Gel, 75% Ethyl alcohol, 95mL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42477-2022	AROMA GUARDIAN (ANTI BACTERIAL INSTANT HAND SANITIZER) GEL [OPAL COSMETICS (HUIZHOU) LIMITED]	1	Legacy NDC	20200417_a36e15e6-8ca0-ffc4-e053-2995a90aecf0.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Aroma Guardian
Anti Bacterial Instant Hand Sanitizer
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
WATER
ALCOHOL
GLYCERIN
TERT-BUTYL ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
42477-2022	42477-2022-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)	59TL3WG5CO	IACT
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	ACTIB
GLYCERIN	PDC6A3C0OX	IACT
TERT-BUTYL ALCOHOL	MD83SFE959	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
a36e15e6-8ca1-ffc4-e053-2995a90aecf0			a36e15e6-8ca0-ffc4-e053-2995a90aecf0	2020-04-17	Warnings	Exact identifier spl id: a36e15e6-8ca1-ffc4-e053-2995a90aecf0 spl set id: a36e15e6-8ca0-ffc4-e053-2995a90aecf0

Reported adverse events (FAERS/openFDA)#

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