FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Astera International LLC
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:31:49

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure27 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 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% 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

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

Do not use

OTC - DO NOT USE SECTION

  • in 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.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

118 ML NDC: 77556-580-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

118 ML Hand Sanitizer118 ML Hand Sanitizer

118 ML Hand Rub118 ML Hand Rub

59 ML NDC: 77556-580-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59 ML Hand Sanitizer59 ML Hand Sanitizer59 ML Hand Rub59 ML Hand Rub

354 ML NDC: 77556-580-12

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

354 ML Hand Sanitizer354 ML Hand Sanitizer

354 Hand Rub354 Hand Rub

236 ML NDC: 77556-580-08

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

236 ML Hand Sanitizer236 ML Hand Sanitizer

236 Hand Rub236 Hand Rub

400 ML NDC: 77556-580-13

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

400 ML Hand Sanitizer400 ML Hand Sanitizer400 ML Hand Rub400 ML Hand Rub

473 ML NDC: 77556-580-16

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

473 ML Hand Sanitizer473 ML Hand Sanitizer473 ML Hand Rub473 ML Hand Rub

946 ML NDC: 77556-580-32

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

946 ML Hand Sanitizer946 ML Hand Sanitizer946 ML Hand Rub946 ML Hand Rub

1000 ML NDC: 77556-580-33

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 ML Hand Sanitizer1000 ML Hand Sanitizer

1000 ML Hand Rub1000 ML Hand Rub

2000 ML NDC: 77556-580-67

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2000 ML Hand Sanitizer2000 ML Hand Sanitizer

2000 ML Hand Rub2000 ML Hand Rub

30 ML NDC: 77556-580-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

77556-580-01 1 oz hand sanitizer77556-580-01 1 oz hand sanitizer

77556-580-01 1 oz hand rub77556-580-01 1 oz hand rub

3785 ML NDC: 77556-580-93

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

77556-580-93 128 oz hand sanitizer77556-580-93 128 oz hand sanitizer

77556-580-93 128 oz hand rub77556-580-93 128 oz hand rub

18927 ML NDC: 77556-580-94

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

77556-580-94 640 oz hand sanitizer77556-580-94 640 oz hand sanitizer

77556-580-94 640 oz hand rub77556-580-94 640 oz hand rub

208198 ML NDC: 77556-580-95

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

77556-580-95 7040 oz hand sanitizer77556-580-95 7040 oz hand sanitizer

77556-580-95 7040 oz hand rub77556-580-95 7040 oz hand rub

1040990 ML NDC: 77556-580-97

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

77556-580-97 35200 oz hand sanitizer77556-580-97 35200 oz hand sanitizer

77556-580-97 35200 oz hand rub77556-580-97 35200 oz hand rub

1249190 ML NDC: 77556-580-99

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

77556-580-99 42240 oz hand sanitizer77556-580-99 42240 oz hand sanitizer

77556-580-99 42240 oz hand rub77556-580-99 42240 oz hand rub

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN9
1039339ethanol 0.8 ML/ML Topical SolutionSCD9
1039339ethanol 80 % Topical SolutionSY9

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 12823456789012877556-580-33 33.8 oz Hand Rub.jpg, 77556-580-01 1 oz hand sanitizer.jpg, 77556-580-95 7040 oz hand sanitizer.jpg, a85010c9-49d2-3673-e053-2995a90a88d1.jpg, 77556-580-93 128 oz hand sanitizer.jpg, 77556-580-01 1 oz hand rub.jpg, 77556-580-02 2 oz hand rub.jpg, 77556-580-02 2 oz Hand Sanitizer.jpg, 77556-580-13 13.5 oz Hand Sanitizer.jpg, 77556-580--04 4 oz Hand Sanitizer.jpg, 77556-580-67 67.6 oz hand sanitizer.jpg, 77556-580-16 16 oz Hand Sanitizer.jpg, 77556-580-12 12 oz hand rub.jpg, 77556-580-94 640 oz hand rub.jpg, 77556-580-32 32 oz hand rub.jpg, 77556-580-95 7040 oz hand rub.jpg, 77556-580-67 67.6 oz Hand Rub.jpg, 77556-580-99 42240 oz hand sanitizer.jpg, 77556-580-97 35200 oz hand sanitizer.jpg, 77556-580-16 16 oz hand rub.jpg, 77556-580-32 32 oz Hand Sanitizer.jpg, 77556-580--04 4 oz Hand Rub.jpg, 77556-580-13 13.5 oz hand rub.jpg, 77556-580-99 42240 oz hand rub.jpg, 77556-580-93 128 oz hand rub.jpg, 77556-580-12 12 oz Hand Sanitizer.jpg, 77556-580-08 8 oz hand rub.jpg, 77556-580-08 8 oz Hand Sanitizer.jpg, 77556-580-33 33.8 oz hand sanitizer.jpg, 77556-580-97 35200 oz hand rub.jpg, 77556-580-94 640 oz hand sanitizer.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77556-580-01Hand Sanitizer30 mL in 1 BOTTLELIQUID309
77556-580-02Hand Sanitizer59 mL in 1 BOTTLELIQUID599
77556-580-04Hand Sanitizer118 mL in 1 BOTTLELIQUID1189
77556-580-08Hand Sanitizer236 mL in 1 BOTTLELIQUID2369
77556-580-12Hand Sanitizer354 mL in 1 BOTTLELIQUID3549
77556-580-13Hand Sanitizer400 mL in 1 BOTTLELIQUID4009
77556-580-16Hand Sanitizer473 mL in 1 BOTTLELIQUID4739
77556-580-32Hand Sanitizer946 mL in 1 BOTTLELIQUID9469
77556-580-33Hand Sanitizer1000 mL in 1 BOTTLELIQUID10009
77556-580-67Hand Sanitizer2000 mL in 1 BOTTLELIQUID20009
77556-580-93Hand Sanitizer3785 mL in 1 BOTTLELIQUID37859
77556-580-94Hand Sanitizer18927 mL in 1 CONTAINERLIQUID189279
77556-580-95Hand Sanitizer208198 mL in 1 DRUMLIQUID2081989
77556-580-97Hand Sanitizer1040990 mL in 1 TANKLIQUID10409909
77556-580-99Hand Sanitizer1249190 mL in 1 TANKLIQUID12491909

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77556-58077556-580-04, 77556-580-02, 77556-580-08, 77556-580-12, 77556-580-13, 77556-580-16, 77556-580-32, 77556-580-33, 77556-580-67, 77556-580-93, 77556-580-01, 77556-580-94, 77556-580-95, 77556-580-97, 77556-580-99

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
NameUNIIKind
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML · Source PDF

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 SanitizerALCOHOLAstera International LLCa5189240-19ce-7715-e053-2995a90ad0432025-12-31WarningsExact identifier
ndc (package): 77556-580-97
ndc (package): 77556-580-13
ndc (package): 77556-580-01
ndc (package): 77556-580-12
ndc (package): 77556-580-94
ndc (package): 77556-580-99
ndc (package): 77556-580-93
ndc (package): 77556-580-32
ndc (package): 77556-580-02
ndc (package): 77556-580-04
ndc (package): 77556-580-08
ndc (package): 77556-580-16
ndc (package): 77556-580-33
ndc (package): 77556-580-67
ndc (package): 77556-580-95
ndc (product): 77556-580
ndc11 (package): 77556058094
ndc11 (package): 77556058032
ndc11 (package): 77556058093
ndc11 (package): 77556058099
ndc11 (package): 77556058001
ndc11 (package): 77556058002
ndc11 (package): 77556058013
ndc11 (package): 77556058067
ndc11 (package): 77556058012
ndc11 (package): 77556058008
ndc11 (package): 77556058095
ndc11 (package): 77556058016
ndc11 (package): 77556058097
ndc11 (package): 77556058004
ndc11 (package): 77556058033
spl id: 473aaaa2-fbd0-c3fe-e063-6294a90a45f0
spl set id: a5189240-19ce-7715-e053-2995a90ad043

Reported adverse events (FAERS/openFDA)#

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