Crooked Creek Distillery Inc Hand Sanitizer

Manufacturer
Crooked Creek Distillery Inc
Effective date
2020-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:04:11

Label at a glance#

ProductCrooked Creek Distillery Inc Hand Sanitizer
Active ingredientALCOHOL
Label structure2 sections

Label contents#

Full prescribing information#

Front Label50ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CROOKED CREEK DSITLLERY

HAND SANITIZER

Alcohol Antiseptic 80% - Topical Solution

Hand Sanitizer - Non-sterile Solution - [50mL]

Produced to World Health Organization (WHO) formulas and to production and labeling requirements as established and approved by the Federal Drug Administration (FDA)

FDA Label ID – 74072

DUNS 096927542

Front LabelFront Label

Back Label50ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts

Active ingredient[s] Purpose

Alcohol 80% v/v.….......................................................................................................................Antiseptic

Use[s]

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

Warnings

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 eyes 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.

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 information

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

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

FDA encourages consumers and health care professionals to report adverse events experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program:

Complete and submit the report online; or
Download and complete the form, then submit it via fax at 1-800-FDA-0178.

Batch ID: Date Produced:

Back Label50mlBack Label50ml

Purpose

OTC - PURPOSE SECTION

Purpose

Antiseptic

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredient[s]
Alcohol 80% v/v

Warnings

WARNINGS SECTION

Warnings

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

Do Not Use

OTC - DO NOT USE SECTION

Do not use

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

Stop use and ask a doctor

OTC - STOP USE SECTION

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

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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

Questions and Concerns

OTC - QUESTIONS SECTION

FDA encourages consumers and health care professionals to report adverse events experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program:

Complete and submit the report online; or
Download and complete the form, then submit it via fax at 1-800-FDA-0178.

Batch Tracking and Production Date

DESCRIPTION SECTION

Batch ID:

Date Produced:

Usage

OTC - WHEN USING SECTION

Use[s]

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

When Using

OTC - WHEN USING SECTION

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

Indications and Usage

INDICATIONS & USAGE SECTION

Use[s]

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

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

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Directions

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.

Storage

STORAGE AND HANDLING SECTION

Other information

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

Dosage and Administration

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 information

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

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
74072-100-072022-01-28C16284748780-1d6a99b39-a226-a426-e053-dadaa90af4c2a1b96ae1-8111-0c34-e053-2995a90a1acd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74072-100-07Crooked Creek Distillery Inc Hand Sanitizer50 mL in 1 BOTTLELIQUID501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74072-100CROOKED CREEK DISTILLERY INC HAND SANITIZER (ALCOHOL) LIQUID [CROOKED CREEK DISTILLERY INC]1Legacy NDC, 1 package rows20200327_a1b96ae1-8111-0c34-e053-2995a90a1acd.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
74072-10074072-100-07

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
ALCOHOL3K9958V90MACTIB
HYDROGEN PEROXIDEBBX060AN9VIACT

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
a1b96ae1-8112-0c34-e053-2995a90a1acda1b96ae1-8111-0c34-e053-2995a90a1acd2020-03-25WarningsExact identifier
spl id: a1b96ae1-8112-0c34-e053-2995a90a1acd
spl set id: a1b96ae1-8111-0c34-e053-2995a90a1acd

Reported adverse events (FAERS/openFDA)#

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