FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Germ Guards Incorporated | Nantong Health & Beyond Hygienic Products Inc.
Effective date
2017-06-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:50:00

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Storage and handling

Store below 110 F/43 C

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient
Ethyl Alcohol 62%

OTC - PURPOSE SECTION

Purpose
Antimicrobial

WARNINGS SECTION

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Do not use in or near eyes. If eye contact occurs, flush thoroughly with water and seek medical care.

Avoid contact with broken skin.

Ingestion may cause alcohol poisoning. If ingested, contact a physician or local poison control center.

OTC - STOP USE SECTION

Stop use and seek medical attention if irritation or redness occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Pour product in hands.
  • Rub together
  • Let dry
  • For children under 6, use only under adult supervision.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Aloe Barbadenis Leaf Juice, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance

INDICATIONS & USAGE SECTION

Uses

  • To decrease bacteria on the skin that could cause disease.
  • Recommended for repeated use.

Other Information

STORAGE AND HANDLING SECTION

Store below 110 F/43 C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of bottle labelimage of bottle label

image of bottle labelimage of bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN2
581660ethanol 0.62 ML/ML Topical GelSCD2
581660ethanol 62 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71089-002-012024-01-30C16284748780-11030e365-20c8-111a-e063-dadaa90a10e24f188d59-f854-3f99-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71089-002-01Hand Sanitizer29 mL in 1 BOTTLEGEL292

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71089-002HAND SANITIZER (ETHYL ALCOHOL) GEL [GERM GUARDS INCORPORATED]2Legacy NDC, 1 package rows20170601_4f188d59-f854-3f99-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71089-00271089-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
TROLAMINE9O3K93S3TKIACT

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
50e66bbc-a4b3-501d-e054-00144ff8d46c4f188d59-f854-3f99-e054-00144ff88e882017-06-01WarningsExact identifier
spl id: 50e66bbc-a4b3-501d-e054-00144ff8d46c
spl set id: 4f188d59-f854-3f99-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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