FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Ole Smoky Distillery, LLC
Effective date
2020-04-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:34:38

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80 % v/v

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • In children less than 2 months of age
  • On open skin wounds

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.

DOSAGE & ADMINISTRATION SECTION

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 SAFETY INFORMATION

Other Information:

Store between 15-30c (59-86F)

Avoid freezing and excessive heat above 40 C (104F)

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

Hand Sanitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

18927.1 ml NDC: 74290-001-01

18927.1 ml front label18927.1 ml front label18927.1 ml back label18927.1 ml back label

750 ml NDC: 74290-001-04

750 ml base label750 ml base label750 ml top label750 ml top label

50 ml NDC: 74290-001-02 50 ml top label50 ml top label 50 ml base label50 ml base label59.1471 ml NDC: 74290-001-03 59.1471 ml front label59.1471 ml front label 59.1471 ml back label59.1471 ml back label

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
74290-00174290-001-01, 74290-001-02, 74290-001-03, 74290-001-04

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
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
b7c96f00-dd53-cb41-e053-2a95a90a4c03a1f3cb5a-a09c-8390-e053-2a95a90ac29a2020-12-31WarningsExact identifier
spl set id: a1f3cb5a-a09c-8390-e053-2a95a90ac29a

Reported adverse events (FAERS/openFDA)#

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