FDA.reportPublic FDA data

Hand San 510D

Manufacturer
DuBois Chemicals, Inc. | Horizon Tool, Inc.
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:10:42

Label at a glance#

ProductHand San 510D
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Directions • 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.

Label contents#

Full prescribing information#

Active ingredient section Hand San 510D

OTC - ACTIVE INGREDIENT SECTION

Active ingredient[s] Purpose
Alcohol 80% v/v ...................................................................................................Antiseptic

Purpose Section Hand San 510D

OTC - PURPOSE SECTION

Use[s]
Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warning Section Hand San 510D

WARNINGS SECTION

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

Do Not Use section Hand San 510D

OTC - DO NOT USE SECTION

Do not use
• in children less than 2 months of age
• on open skin wounds

When Using Hand San 510D

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 Hand San 510D

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of Reach Hand San 510D

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 Hand San 510D

CLEANING, DISINFECTING, AND STERILIZATION INSTRUCTIONS

Directions
• 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 Hand San 510D

OTHER SAFETY INFORMATION

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

Inactive Hand San 510D

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

Dosage

DOSAGE & ADMINISTRATION SECTION

Use[s]
Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Directions
• 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.

Indications

INDICATIONS & USAGE SECTION

Use[s]
Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Directions
• 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.

Display Panel Hand San 510D

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottlePailPailDrumDrumHAND SAN 510D
Alcohol Antiseptic 80%
Topical Solution
Hand Sanitizer
Non-sterile Solution

18.9L

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44395-1112-12022-01-31C16284748780-1d6a99b39-ddc0-a426-e053-dadaa90af4c2Hand San 510D
44395-1112-22022-01-31C16284748780-1d6a99b39-ddc0-a426-e053-dadaa90af4c2Hand San 510D
44395-1112-32022-01-31C16284748780-1d6a99b39-ddc0-a426-e053-dadaa90af4c2Hand San 510D
44395-1112-42022-01-31C16284748780-1d6a99b39-ddc0-a426-e053-dadaa90af4c2Hand San 510D
44395-1112-52022-01-31C16284748780-1d6a99b39-ddc0-a426-e053-dadaa90af4c2Hand San 510D
44395-1112-12022-01-28C16284748780-1d6a99b39-ddc0-a426-e053-dadaa90af4c2Hand San 510D
44395-1112-22022-01-28C16284748780-1d6a99b39-ddc0-a426-e053-dadaa90af4c2Hand San 510D
44395-1112-32022-01-28C16284748780-1d6a99b39-ddc0-a426-e053-dadaa90af4c2Hand San 510D
44395-1112-42022-01-28C16284748780-1d6a99b39-ddc0-a426-e053-dadaa90af4c2Hand San 510D
44395-1112-52022-01-28C16284748780-1d6a99b39-ddc0-a426-e053-dadaa90af4c2Hand San 510D

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
44395-111244395-1112-1, 44395-1112-2, 44395-1112-3, 44395-1112-4, 44395-1112-5

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
d58ee756-c609-ff9e-e053-2995a90ac6e4a1daa13c-8a94-efb0-e053-2995a90a9fb32022-01-14WarningsExact identifier
spl id: d58ee756-c609-ff9e-e053-2995a90ac6e4
spl set id: a1daa13c-8a94-efb0-e053-2995a90a9fb3

Reported adverse events (FAERS/openFDA)#

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