HydraGen Pro Barrier Hand Sanitizer

Manufacturer
ADVANCED SKIN TECHNOLOGY, LLC | Pure Source, LLC
Effective date
2020-06-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:18:18

Label at a glance#

ProductHydraGen Pro Barrier Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

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

Dosage and administration

Place enough product in your palm to thoroughly cover your hands. Rub hands briskly until they are fully dry.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antispetic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For external use only.

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs.

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.

OTC - DO NOT USE SECTION

Do Not Use

  • In children less than 2 months of age.
  • On open skin wounds

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product in your palm to thoroughly cover your hands.
  • Rub hands briskly until they are fully dry.

Other Information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, hydrolized jojoba esters, glycerin, PEG-10 dimethicone, sodium hyaluronate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HydraGen

Pro Barrier Hand Sanitizer

with hyaluronic acid

5.7 fl. oz /168 ml

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
247835ethanol 62 % Topical SolutionPSN1
247835ethanol 0.62 ML/ML Topical SolutionSCD1
247835ethanol 62 % Topical SolutionSY1
247835ethyl alcohol 62 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52205-004-012024-01-30C16284748780-11030e365-606c-111a-e063-dadaa90a10e2HydraGen® Pro Barrier Hand Sanitizer with Hyaluronic Acid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52205-004-01HydraGen Pro Barrier Hand Sanitizer168 mL in 1 BOTTLE, PUMPLIQUID1681

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52205-004HYDRAGEN PRO BARRIER HAND SANITIZER (ALCOHOL) LIQUID [ADVANCED SKIN TECHNOLOGY, LLC]1Legacy NDC, 1 package rows20200619_a84b9cff-86b0-1842-e053-2995a90a8ddf.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52205-00452205-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
a84b9cff-86b1-1842-e053-2995a90a8ddfa84b9cff-86b0-1842-e053-2995a90a8ddf2020-06-18WarningsExact identifier
spl id: a84b9cff-86b1-1842-e053-2995a90a8ddf
spl set id: a84b9cff-86b0-1842-e053-2995a90a8ddf

Reported adverse events (FAERS/openFDA)#

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