FDA.reportPublic FDA data

hand sanitizer

Manufacturer
Pernod Ricard USA | Firestone and Robertson Distillery | Rabbit Hole Spirits | Smooth Ambler Spirits
Effective date
2020-04-14
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:06:16

Label at a glance#

Producthand sanitizer
Active ingredientALCOHOL
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient[s] Purpose

Alcohol 80% v/v ................................. Anitseptic

WARNINGS SECTION

Warnings:

For External use only. Flammable. Keep away from heat and flame

OTC - DO NOT USE SECTION

Do not use

  • in 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 mounth. In case of contact with eyes flush 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 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.

INSTRUCTIONS FOR USE 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 40C (104F)

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

INDICATIONS & USAGE SECTION

Use[s)

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

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.

OTC - PURPOSE SECTION

Use[s)

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

smooth ambler versionsmooth ambler version

Rabbit holeRabbit hole

PRHSPRHS

73785-001-0373785-001-03

73785-001-0473785-001-04

Smooth Ambler 1 galSmooth Ambler 1 gal

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN7
1039339ethanol 0.8 ML/ML Topical SolutionSCD7
1039339ethanol 80 % Topical SolutionSY7

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
73785-001-012022-01-28C16284748780-1d6a99b39-3a2c-a426-e053-dadaa90af4c2Pernod Ricard Hand sanitizer
73785-001-022022-01-28C16284748780-1d6a99b39-3a2c-a426-e053-dadaa90af4c2Pernod Ricard Hand sanitizer
73785-001-032022-01-28C16284748780-1d6a99b39-3a2c-a426-e053-dadaa90af4c2Pernod Ricard Hand sanitizer
73785-001-042022-01-28C16284748780-1d6a99b39-3a2c-a426-e053-dadaa90af4c2Pernod Ricard Hand sanitizer
73785-001-052022-01-28C16284748780-1d6a99b39-3a2c-a426-e053-dadaa90af4c2Pernod Ricard Hand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73785-001-01hand sanitizer750 mL in 1 BOTTLESOLUTION7507
73785-001-02hand sanitizer189271 mL in 1 DRUMSOLUTION1892717
73785-001-03hand sanitizer245000 mL in 1 DRUMSOLUTION2450007
73785-001-04hand sanitizer1225000 mL in 1 DRUMSOLUTION12250007
73785-001-05hand sanitizer3785 mL in 1 JUGSOLUTION37857

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73785-001HAND SANITIZER (ALCOHOL) SOLUTION [PERNOD RICARD USA]7Legacy NDC, 5 package rows20200415_a14cc85c-dc47-585a-e053-2995a90add05.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
73785-00173785-001-01, 73785-001-02, 73785-001-03, 73785-001-04, 73785-001-05

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
HYDROGEN PEROXIDEBBX060AN9VIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT

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
a3467d1c-e28e-7855-e053-2a95a90a8158a14cc85c-dc47-585a-e053-2995a90add052020-04-14WarningsExact identifier
spl id: a3467d1c-e28e-7855-e053-2a95a90a8158
spl set id: a14cc85c-dc47-585a-e053-2995a90add05

Reported adverse events (FAERS/openFDA)#

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