FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Round Bridge Inc
Effective date
2020-05-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:13:56

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Children under 6 years of age should be supervised when using this product.

Storage and handling

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

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

For external use only. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth.

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.
  • Children under 6 years of age should be supervised when using this product.

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

Aqua, Glycerin, Carbomer, Triethanolamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59 ml NDC: 34839-002-01

2oz Clean Panda2oz Clean Panda

118 ml NDC: 34839-002-02

4oz Clean Panda4oz Clean Panda

236 ml NDC: 34839-002-03

8oz Clean Panda8oz Clean Panda

500 ml NDC: 34839-002-04

500ml Clean Panda500ml Clean Panda

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN2
1305100ethanol 0.75 ML/ML Topical GelSCD2
1305100ethanol 75 % Topical GelSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130860003635216GTIN-13: 0860003635216
EAN-13: 0860003635216
GTIN-12: 860003635216
UPC-A: 860003635216
GTIN storage (14 digits): 00860003635216		Clean Panda - Hand Sanitizer 500mL.jpg
BarcodeEAN-130860003635230GTIN-13: 0860003635230
EAN-13: 0860003635230
GTIN-12: 860003635230
UPC-A: 860003635230
GTIN storage (14 digits): 00860003635230		2oz Bullet Clean Panda.jpg
BarcodeEAN-130860003635247GTIN-13: 0860003635247
EAN-13: 0860003635247
GTIN-12: 860003635247
UPC-A: 860003635247
GTIN storage (14 digits): 00860003635247		4oz Bullet Clean Panda.jpg
BarcodeEAN-130860003635254GTIN-13: 0860003635254
EAN-13: 0860003635254
GTIN-12: 860003635254
UPC-A: 860003635254
GTIN storage (14 digits): 00860003635254		8oz Bullet Clean Panda4.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
34839-003-012021-07-23C16284748780-1c7ccaba7-1446-fd44-e053-dadaa90aa01bHand Sanitizer
34839-003-022021-07-23C16284748780-1c7ccaba7-1446-fd44-e053-dadaa90aa01bHand Sanitizer
34839-003-032021-07-23C16284748780-1c7ccaba7-1446-fd44-e053-dadaa90aa01bHand Sanitizer
34839-003-042021-07-23C16284748780-1c7ccaba7-1446-fd44-e053-dadaa90aa01bHand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34839-003-01Hand Sanitizer59 mL in 1 BOTTLEGEL592
34839-003-02Hand Sanitizer118 mL in 1 BOTTLEGEL1182
34839-003-03Hand Sanitizer236 mL in 1 BOTTLEGEL2362
34839-003-04Hand Sanitizer500 mL in 1 BOTTLEGEL5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34839-003HAND SANITIZER (ETHYL ALCOHOL) GEL [ROUND BRIDGE INC]2Legacy NDC, 4 package rows20200521_a5b4a83a-43e1-4ce8-e053-2995a90a0dac.zip

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
34839-00334839-003-02, 34839-003-03, 34839-003-04, 34839-003-01

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
NameUNIIKind
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
a617da69-d54a-e1d9-e053-2995a90a354fa5b4a83a-43e1-4ce8-e053-2995a90a0dac2020-05-20WarningsExact identifier
spl id: a617da69-d54a-e1d9-e053-2995a90a354f
spl set id: a5b4a83a-43e1-4ce8-e053-2995a90a0dac

Reported adverse events (FAERS/openFDA)#

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