FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Whiskey Acres Distilling Company
Effective date
2020-08-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:24:25

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 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

4oz4oz

16oz16oz

32oz32oz

64oz64oz

128oz128oz

640oz640oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2 oz2 oz10 oz10 oz270oz270oz

55gal55gal

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN5
1039339ethanol 0.8 ML/ML Topical SolutionSCD5
1039339ethanol 80 % Topical SolutionSY5

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
74148-111-012021-07-23C16284748780-1c7ccaba7-1f80-fd44-e053-dadaa90aa01bHand sanitizer
74148-111-022021-07-23C16284748780-1c7ccaba7-1f80-fd44-e053-dadaa90aa01bHand sanitizer
74148-111-032021-07-23C16284748780-1c7ccaba7-1f80-fd44-e053-dadaa90aa01bHand sanitizer
74148-111-042021-07-23C16284748780-1c7ccaba7-1f80-fd44-e053-dadaa90aa01bHand sanitizer
74148-111-052021-07-23C16284748780-1c7ccaba7-1f80-fd44-e053-dadaa90aa01bHand sanitizer
74148-111-062021-07-23C16284748780-1c7ccaba7-1f80-fd44-e053-dadaa90aa01bHand sanitizer
74148-111-072021-07-23C16284748780-1c7ccaba7-1f80-fd44-e053-dadaa90aa01bHand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74148-111-01Hand Sanitizer118.294 mL in 1 BOTTLELIQUID118.2945
74148-111-02Hand Sanitizer473.176 mL in 1 BOTTLELIQUID473.1765
74148-111-03Hand Sanitizer946.353 mL in 1 BOTTLELIQUID946.3535
74148-111-04Hand Sanitizer1892.71 mL in 1 BOTTLELIQUID1892.715
74148-111-05Hand Sanitizer3785.41 mL in 1 BOTTLELIQUID3785.415
74148-111-06Hand Sanitizer18927.1 mL in 1 BOTTLELIQUID18927.15
74148-111-07Hand Sanitizer1022 mL in 1 BOTTLELIQUID10225

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74148-111HAND SANITIZER (ALCOHOL) LIQUID [WHISKEY ACRES DISTILLING COMPANY]5Legacy NDC, 7 package rows20200812_a1ec0b02-aee2-1740-e053-2995a90ab1b5.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
74148-11174148-111-02, 74148-111-01, 74148-111-03, 74148-111-04, 74148-111-05, 74148-111-06, 74148-111-07

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
ac9e6cfd-1d80-a7ed-e053-2a95a90ab732a1ec0b02-aee2-1740-e053-2995a90ab1b52020-08-11WarningsExact identifier
spl id: ac9e6cfd-1d80-a7ed-e053-2a95a90ab732
spl set id: a1ec0b02-aee2-1740-e053-2995a90ab1b5

Reported adverse events (FAERS/openFDA)#

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