FDA.reportPublic FDA data

Azer Hand Sanitizer

Manufacturer
Azer Scientific, Inc. | Soleo Cosmetic Co., Ltd.
Effective date
2020-04-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:05:38

Label at a glance#

ProductAzer Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

Spread on both hands, rub in, let dry. Change from COVID template to match current labeling

Storage and handling

Store at room temperature 34~86°F (1~30°C)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 62% v/v. Purpose: Antimicrobial

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin

CASECASE

Warnings

WARNINGS SECTION

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

When using this product Avoid contact with eyes, ears, mouth, entire body, or damaged skins.
Stop use and ask a doctor If redness or irritation develop and persist.
Keep out of reach of children If swallowed, get medical help or contact a Sanitizer Gel Poison Control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Spread on both hands, rub in, let dry.

Dosage and administration changes

RECENT MAJOR CHANGES SECTION

Change from COVID template to match current labeling

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature 34~86°F (1~30°C)
  • boxbox

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Carbomer, Butylene Glycol, Phenoxyethanol, Arginine, Mugwort Extract, Yeast Extract, Luffa Extract, Fragrance

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Purpose

OTC - PURPOSE SECTION

Hand sanitizer to help reduce bacteria on the skin

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BOTTLE LABELBOTTLE LABELCASE LABELCASE LABELBOXBOX16.9 fl. oz. (500 mL) NDC: 74086-650-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN1
581660ethanol 0.62 ML/ML Topical GelSCD1
581660ethanol 62 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74086-650-022022-01-28C16284748780-1d6a99b39-3a62-a426-e053-dadaa90af4c2Azer Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74086-650-02Azer Hand Sanitizer500 mL in 1 BOTTLE, DISPENSINGGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74086-650AZER HAND SANITIZER (ALCOHOL) GEL [AZER SCIENTIFIC, INC.]1Legacy NDC, 1 package rows20200410_a2a55e3f-6e9c-3265-e053-2995a90af317.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74086-65074086-650-02

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
NameUNIIKind
BUTYLENE GLYCOL3XUS85K0RAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
ARGININE94ZLA3W45FIACT
CARBOMER 9404Q93RCW27EIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
ARTEMISIA PRINCEPS LEAFSY077EW02GIACT
WATER059QF0KO0RIACT
LUFFAF0R3Y60C6VIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a2a568de-7b76-09e5-e053-2995a90ac590a2a55e3f-6e9c-3265-e053-2995a90af3172020-04-06WarningsExact identifier
spl id: a2a568de-7b76-09e5-e053-2995a90ac590
spl set id: a2a55e3f-6e9c-3265-e053-2995a90af317

Reported adverse events (FAERS/openFDA)#

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