FDA.reportPublic FDA data

Safe Cleaner Hand Sanitizer Gel

Manufacturer
S ONE pharmaceutical inc.
Effective date
2020-06-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:17:02

Label at a glance#

ProductSafe Cleaner Hand Sanitizer Gel
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Alcohol

INACTIVE INGREDIENT SECTION

water, carbomer, etc

OTC - PURPOSE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children

INDICATIONS & USAGE 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.

WARNINGS SECTION

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

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse 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.

DOSAGE & ADMINISTRATION SECTION

for external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

100ml NDC: 74721-0001-2 Label100ml NDC: 74721-0001-2 Label

250ml NDC: 74721-0001-3 Label250ml NDC: 74721-0001-3 Label

300ml NDC: 74721-0001-4 Label300ml NDC: 74721-0001-4 Label475ml NDC: 74721-0001-5 Label475ml NDC: 74721-0001-5 Label

1000ml NDC: 74721-0001-6 Label1000ml NDC: 74721-0001-6 Label

1000ml NDC: 74721-0001-7 Label1000ml NDC: 74721-0001-7 Label

2000ml NDC: 74721-0001-8 Label2000ml NDC: 74721-0001-8 Label

4000ml NDC: 74721-0001-9 Label4000ml NDC: 74721-0001-9 Label

2ml NDC: 74721-0001-0 Label2ml NDC: 74721-0001-0 Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74721-0001-02023-01-30C16284748780-1f386c64a-1cba-0266-e053-dadaa90a7c1a74721-0001
74721-0001-12023-01-30C16284748780-1f386c64a-1cba-0266-e053-dadaa90a7c1a74721-0001
74721-0001-22023-01-30C16284748780-1f386c64a-1cba-0266-e053-dadaa90a7c1a74721-0001
74721-0001-32023-01-30C16284748780-1f386c64a-1cba-0266-e053-dadaa90a7c1a74721-0001
74721-0001-42023-01-30C16284748780-1f386c64a-1cba-0266-e053-dadaa90a7c1a74721-0001
74721-0001-52023-01-30C16284748780-1f386c64a-1cba-0266-e053-dadaa90a7c1a74721-0001
74721-0001-62023-01-30C16284748780-1f386c64a-1cba-0266-e053-dadaa90a7c1a74721-0001
74721-0001-72023-01-30C16284748780-1f386c64a-1cba-0266-e053-dadaa90a7c1a74721-0001
74721-0001-82023-01-30C16284748780-1f386c64a-1cba-0266-e053-dadaa90a7c1a74721-0001
74721-0001-92023-01-30C16284748780-1f386c64a-1cba-0266-e053-dadaa90a7c1a74721-0001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74721-0001-0Safe Cleaner Hand Sanitizer Gel2 mL in 1 POUCHGEL23
74721-0001-1Safe Cleaner Hand Sanitizer Gel500 mL in 1 BOTTLE, PUMPGEL5003
74721-0001-2Safe Cleaner Hand Sanitizer Gel100 mL in 1 BOTTLEGEL1003
74721-0001-3Safe Cleaner Hand Sanitizer Gel250 mL in 1 BOTTLEGEL2503
74721-0001-4Safe Cleaner Hand Sanitizer Gel300 mL in 1 BOTTLEGEL3003
74721-0001-5Safe Cleaner Hand Sanitizer Gel475 mL in 1 BOTTLEGEL4753
74721-0001-6Safe Cleaner Hand Sanitizer Gel1000 mL in 1 BOTTLE, PUMPGEL10003
74721-0001-7Safe Cleaner Hand Sanitizer Gel1000 mL in 1 BOTTLEGEL10003
74721-0001-8Safe Cleaner Hand Sanitizer Gel2000 mL in 1 BOTTLEGEL20003
74721-0001-9Safe Cleaner Hand Sanitizer Gel4000 mL in 1 BOTTLEGEL40003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74721-0001SAFE CLEANER HAND SANITIZER GEL (ALCOHOL) GEL [S ONE PHARMACEUTICAL INC.]3Legacy NDC, 10 package rows20200611_a2c0e052-5c37-1951-e053-2995a90a32ec.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74721-000174721-0001-1, 74721-0001-2, 74721-0001-3, 74721-0001-4, 74721-0001-5, 74721-0001-6, 74721-0001-7, 74721-0001-8, 74721-0001-9, 74721-0001-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
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
a7b52a3d-995e-7304-e053-2a95a90a0b69a2c0e052-5c37-1951-e053-2995a90a32ec2020-06-10WarningsExact identifier
spl id: a7b52a3d-995e-7304-e053-2a95a90a0b69
spl set id: a2c0e052-5c37-1951-e053-2995a90a32ec

Reported adverse events (FAERS/openFDA)#

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