FDA.reportPublic FDA data

Pristine Clean Hand Sanitizer- Medical Grade

Manufacturer
High Mark Distillery, Inc. DBA: High Mark Barrel House, Inc.
Effective date
2020-06-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:28

Label at a glance#

ProductPristine Clean Hand Sanitizer- Medical Grade
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Denatured Ethyl Alcohol ABV 80%

PURPOSE:

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

USES: Sanitizer to decrease bacteria on the skin. May decrease up to 99.99% of Viruses on contact when properly used.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: ​Wet hands thoroughly with sanitizer. Briskly rub hands together until dry. Supervise children under 6 years in use of sanitizer.

WARNINGS SECTION

WARNINGS: FLAMMABLE- Do not use near heat, fire, flame, or while smoking. Do not store where temperature exceeds 105 Degrees F. May discolor certain fabrics.

FOR EXTERNAL USE ONLY: DO NOT GET IN EYES. In case of eye contact flush thoroughly with water. Do not inhale or ingest. If swallowed, get medical help, and drink water to flush out of system. Stop use and ask a doctor if skin irritation develops.

DO NOT USE ON: Burns or Open Wounds

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN: ​If swallowed, get medical help immediately, and drink water to flush out of system.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: ​Distilled Water, Hydrogen Peroxide, Glycerin, Plant Food Color-Blue.

SPL UNCLASSIFIED SECTION

HANDCRAFTED IN AMERICA* AMERICAN SPIRITS, CROPS, AND WORKERS

HIGH MARK DISTILLERY

100% MADE IN USA

Produced and Bottled by: High Mark Distillery; Inc. Reno, NV

WWW.highmarkdistillery.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN1
1041498ethanol 0.8 ML/ML Topical GelSCD1
1041498ethanol 80 % Topical GelSY1

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
78288-201-032022-01-28C16284748780-1d6a99b39-7629-a426-e053-dadaa90af4c2HIGH MARK DISTILLERY PRISTINE CLEAN MEDICAL GRADE HAND SANITIZER
78288-201-082022-01-28C16284748780-1d6a99b39-7629-a426-e053-dadaa90af4c2HIGH MARK DISTILLERY PRISTINE CLEAN MEDICAL GRADE HAND SANITIZER
78288-201-122022-01-28C16284748780-1d6a99b39-7629-a426-e053-dadaa90af4c2HIGH MARK DISTILLERY PRISTINE CLEAN MEDICAL GRADE HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78288-201-03Pristine Clean Hand Sanitizer- Medical Grade88.7 mL in 1 BOTTLELIQUID88.71
78288-201-08Pristine Clean Hand Sanitizer- Medical Grade236.59 mL in 1 BOTTLELIQUID236.591
78288-201-12Pristine Clean Hand Sanitizer- Medical Grade360 mL in 1 BOTTLELIQUID3601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78288-201PRISTINE CLEAN HAND SANITIZER- MEDICAL GRADE (ETHYL ALCOHOL) LIQUID [HIGH MARK DISTILLERY, INC. DBA: HIGH MARK BARREL HOUSE, INC.]1Legacy NDC, 3 package rows20200630_7020bba5-bb40-408f-91e6-52afb2f9fddf.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78288-20178288-201-03, 78288-201-08, 78288-201-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
GLYCERINPDC6A3C0OXIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
9460793d-4a22-4600-8e1e-b0bf650ab2477020bba5-bb40-408f-91e6-52afb2f9fddf2020-06-09WarningsExact identifier
spl id: 9460793d-4a22-4600-8e1e-b0bf650ab247
spl set id: 7020bba5-bb40-408f-91e6-52afb2f9fddf

Reported adverse events (FAERS/openFDA)#

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