FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Avaria Health & Beauty Corp
Effective date
2025-10-08
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:38:36

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure14 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

Store between 15 - 40C (59 - 86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%. 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

For external use only

Flammable. Keep away from heat and flame.

Do not use

OTC - DO NOT USE SECTION

  • In children less than 2 months of age.
  • On open skin wounds.

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

  • Store between 15 - 40C (59 - 86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Carbomer, Hyaluronic Acid, Aminomethyl Propanol ,Isopropyl Myristate

RECENT MAJOR CHANGES SECTION

Uses

Warnings

Dosage and Administration

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1.888.829.7165

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

13.5 fl oz (400 ml)

NDC 43493-0000-0

front panelfront panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN8
581662ethanol 0.7 ML/ML Topical GelSCD8
581662ethanol 70 % Topical GelSY8
581662ethyl alcohol 70 % Topical GelSY8

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130691808110208GTIN-13: 0691808110208
EAN-13: 0691808110208
GTIN-12: 691808110208
UPC-A: 691808110208
GTIN storage (14 digits): 00691808110208		Hand_Sanitizer_400mL-US_V3.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43493-0000-0Hand Sanitizer400 mL in 1 BOTTLE, PUMPGEL4008
43493-0000-1Hand Sanitizer250 mL in 1 BOTTLE, PUMPGEL2508
43493-0000-2Hand Sanitizer60 mL in 1 BOTTLE, PUMPGEL608
43493-0000-3Hand Sanitizer1000 mL in 1 BOTTLE, PUMPGEL10008

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43493-000043493-0000-0, 43493-0000-1, 43493-0000-2, 43493-0000-3

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
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
HYALURONIC ACIDS270N0TRQYIACT
WATER059QF0KO0RIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72024-10-17full-release2026-06-01 00:28:34

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
Hand SanitizerALCOHOLAvaria Health & Beauty Corpa3d87ef6-752b-b54b-e053-2a95a90af9632025-10-08WarningsExact identifier
ndc (package): 43493-0000-3
ndc (package): 43493-0000-2
ndc (package): 43493-0000-1
ndc (package): 43493-0000-0
ndc (product): 43493-0000
ndc11 (package): 43493000003
ndc11 (package): 43493000000
ndc11 (package): 43493000002
ndc11 (package): 43493000001
spl id: 40a75635-037e-98d4-e063-6394a90a4868
spl set id: a3d87ef6-752b-b54b-e053-2a95a90af963

Reported adverse events (FAERS/openFDA)#

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