FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
CUNNINGHAM SPIRITS LLC dba OLD GLORY DISTILLING CO.
Effective date
2020-05-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:13:53

Label at a glance#

ProductHAND SANITIZER
Active ingredientAlcohol
Label structure9 sections

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use[s]

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. Flammable.

Keep away from heat or flame.

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

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.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

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

glycerin, hydrogen peroxide, purified water USP

PRINCIPAL DISPLAY PANEL - 1892.7 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DISTILLED & BOTTLED BY
Old
GLORY
DISTILLING • Co
CLARKSVILLE, TN

HAND
SANITIZER
ALCOHOL
ANTISEPTIC 80%
TOPICAL SOLUTION

NON-STERILE
SOLUTION
WHO-RECOMMENDED
HANDRUB

1/2 GALLON | 1.89L (1892.7ML) | 64 OUNCES

Principal Display Panel - 1892.7 ML Bottle Label
Principal Display Panel - 1892.7 ML Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76872-101-012022-01-28C16284748780-1d6a99b39-585e-a426-e053-dadaa90af4c2HAND SANITIZER
76872-101-022022-01-28C16284748780-1d6a99b39-585e-a426-e053-dadaa90af4c2HAND SANITIZER
76872-101-032022-01-28C16284748780-1d6a99b39-585e-a426-e053-dadaa90af4c2HAND SANITIZER
76872-101-042022-01-28C16284748780-1d6a99b39-585e-a426-e053-dadaa90af4c2HAND SANITIZER
76872-101-052022-01-28C16284748780-1d6a99b39-585e-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76872-101-01HAND SANITIZER1892.71 mL in 1 JUGLIQUID1892.711
76872-101-02HAND SANITIZER3785.41 mL in 1 JUGLIQUID3785.411
76872-101-03HAND SANITIZER18927.1 mL in 1 PAILLIQUID18927.11
76872-101-04HAND SANITIZER208198 mL in 1 DRUMLIQUID2081981
76872-101-05HAND SANITIZER1022061.2 mL in 1 CONTAINERLIQUID1022061.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76872-101HAND SANITIZER (ALCOHOL) LIQUID [CUNNINGHAM SPIRITS LLC DBA OLD GLORY DISTILLING CO.]1Legacy NDC, 5 package rows20200521_54a3b83c-6fd1-4cac-b7f7-e430957cdcc1.zip

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
76872-10176872-101-01, 76872-101-02, 76872-101-03, 76872-101-04, 76872-101-05

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
Alcohol3K9958V90MACTIB
glycerinPDC6A3C0OXIACT
hydrogen peroxideBBX060AN9VIACT
water059QF0KO0RIACT

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
a7b0b489-b5d4-4823-ad09-61af760412e654a3b83c-6fd1-4cac-b7f7-e430957cdcc12020-05-19WarningsExact identifier
spl id: a7b0b489-b5d4-4823-ad09-61af760412e6
spl set id: 54a3b83c-6fd1-4cac-b7f7-e430957cdcc1

Reported adverse events (FAERS/openFDA)#

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