Nelsons Green Brier Hand Sanitizer

Manufacturer
Nelson's Green Brier Distillery, LLC
Effective date
2020-04-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:08:14

Label at a glance#

ProductNelsons Green Brier Hand Sanitizer
Active ingredientALCOHOL
Label structure14 sections

Dosage and administration

Directions Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient[s]/ Purpose

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

Do Not Use

OTC - DO NOT USE SECTION

Do not use

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

Purpose:

OTC - PURPOSE SECTION

Use[s]

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

Stop Use

OTC - STOP USE SECTION

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

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.

Other Information

OTHER SAFETY INFORMATION

Other Information

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

Warnings and Precautions

WARNINGS AND PRECAUTIONS SECTION

Warnings

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

Inacative Ingredients Section

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

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 when using this product to avoid swallowing.

Warning

WARNINGS SECTION

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

Indications & Usage Section

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

Keep out of Reach

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Recent Major Changes Section

N/A Original Label

When substantive labeling changes have been made to any of the following sections of the FPI within the preceding 12 months, the heading(s) of the changed section(s) must be listed in Highlights under the heading Recent Major Changes (§ 201.57(a)(5)):

• Boxed Warning
• Indications and Usage
• Dosage and Administration
• Contraindications
• Warnings and Precautions


Changes that must not be listed in Recent Major Changes include:

• Changes to sections other than the five listed above
• Changes that are not substantive (i.e., minor revisions such as correcting typographical errors or grammatical changes)
• Changes resulting from converting to the PLR format alone


a. What must be included ?
Each listing must include the section heading, the subsection heading (if appropriate), identifying number of the corresponding changed section or subsection, and the date on which the change was incorporated in the labeling (i.e., date the supplement was approved) in month/year format (e.g., 6/2010 or Jun 2010) (§ 201.57(a)(5)).

Primary Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nelson's

Green Brier

Distillery

Alcohol Antiseptic 80%

Topical Solution

Hand Sanitizer

Non-sterile Solution

118.3mL

Not for Resale

Not for Consumption

Nelson's Green Brier Hand SanitizerNelson's Green Brier Hand Sanitizer

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
74204-003-012021-07-23C16284748780-1c7ccaba7-1710-fd44-e053-dadaa90aa01ba3869af3-1af2-24d2-e053-2a95a90ae3aa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74204-003-01Nelsons Green Brier Hand Sanitizer118.3 mL in 1 BOTTLE, PLASTICLIQUID118.31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74204-003NELSONS GREEN BRIER HAND SANITIZER (ALCHOL) LIQUID [NELSON'S GREEN BRIER DISTILLERY, LLC]1Legacy NDC, 1 package rows20200428_a3869af3-1af2-24d2-e053-2a95a90ae3aa.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74204-00374204-003-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
a3869af3-1af3-24d2-e053-2a95a90ae3aaa3869af3-1af2-24d2-e053-2a95a90ae3aa2020-04-17WarningsExact identifier
spl id: a3869af3-1af3-24d2-e053-2a95a90ae3aa
spl set id: a3869af3-1af2-24d2-e053-2a95a90ae3aa

Reported adverse events (FAERS/openFDA)#

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