FDA.reportPublic FDA data

GelpHresh

Manufacturer
Brainerd Chemical Company Inc.,
Effective date
2020-06-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:00

Label at a glance#

ProductGelpHresh
Active ingredientalcohol
Label structure9 sections

Dosage and administration

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 and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • 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 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. 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

hydrogen peroxide, purified water USP, d-limonene, cocamidopropyl betaine, hydroxypropyl methylcellulose

PRINCIPAL DISPLAY PANEL - 18.9 L Jug Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Prevenio

Gelphresh

Isopropyl Alcohol Antiseptic 75% (Gel)
Topical Solution
Hand Sanitizer
Non-sterile Solution

DANGER

Hazard Statements: Highly flammable liquid and vapor. Causes serious eye
irritation. May cause drowsiness or dizziness.

Precautionary Statements: Keep away from heat, open flames, sparks -- No
smoking. Keep container tightly closed. Ground/bond container and receiving
equipment. Use explosion-proof electrical, ventilating
away from clothing. Use only non-sparking tools. Take precautionary measures
against static discharge. Avoid breathing dust, fume, gas, mist, vapors and spray.
Wear protective gloves, clothing, eye and face protection.

IF IN EYES: Rinse cautiously with water for several minutes.
Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation
persists, seek medical advice/attention.
SPECIFIC TREATMENT: (See First Aid section on the SDS.) Rinse mouth.
Wash contaminated clothing before reuse.
IN CASE OF FIRE: Use dry san, dry chemical or alcohol-resistant foam to extinguish.
Store in a well-ventilated place. Keep container tightly closed. Store in well-
ventilated place. Keep cool. Store locked up.
Dispose of contents/container to licensed waste handling facility.

UPC
CODE
PLACEHOLDER

MADE
IN THE
USA

NET CONTENTS: 5 GAL / 18.9 L

LOT #: _____________________

CMS PRODUCT # 8005

UN 1987

UN 1987, ALCOHOLS, N.O.S.,
(ISOPROPYL ALCOHOL), 3, PG III

FOR SPILL EMERGENCIES 24-HOUR

CALL INFOTRAC @ 800.535.5053 (US & Canada) | 352.323.3500 (Outside US & Canada)
PLEASE REFERENCE SDS FOR ADDITIONAL INFORMATION

KEEP OUT OF THE REACH OF CHILDREN.
FOR INDUSTRIAL OR FOOD PLANT USE ONLY

PROTECTING
BRANDS by
PROTECTING
LIVES

Prevenio | 10 Finderne Avenue | Bridgewater, NJ 08807 | 908.707.1092 | www.prevenio.com

PRINCIPAL DISPLAY PANEL - 18.9 L Jug Label
PRINCIPAL DISPLAY PANEL - 18.9 L Jug Label

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
54555-130-012022-01-28C16284748780-1d6a99b39-c294-a426-e053-dadaa90af4c2GelpHresh
54555-130-022022-01-28C16284748780-1d6a99b39-c294-a426-e053-dadaa90af4c2GelpHresh
54555-130-032022-01-28C16284748780-1d6a99b39-c294-a426-e053-dadaa90af4c2GelpHresh
54555-130-042022-01-28C16284748780-1d6a99b39-c294-a426-e053-dadaa90af4c2GelpHresh

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54555-130-01GelpHresh3.785 L in 1 JUGLIQUID3.7851
54555-130-02GelpHresh18.9 L in 1 JUGLIQUID18.91
54555-130-03GelpHresh208.1 L in 1 DRUMLIQUID208.11
54555-130-04GelpHresh1040.9 L in 1 TANKLIQUID1040.91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54555-130GELPHRESH (ALCOHOL) LIQUID [BRAINERD CHEMICAL COMPANY INC.,]1Legacy NDC, 4 package rows20200611_2e67df4c-edbf-4df1-903f-4fa25e1e7195.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
54555-13054555-130-04, 54555-130-03, 54555-130-02, 54555-130-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
alcohol3K9958V90MACTIB
Cocamidopropyl Betaine5OCF3O11KXIACT
hydrogen peroxideBBX060AN9VIACT
water059QF0KO0RIACT
LIMONENE OXIDE, TRANS-(+)-8VUQ1B30IKIACT
HYDROXYMETHYL CELLULOSE273FM27VK1IACT

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
83f35c81-93cb-4307-8f6b-1484d9c5d1b42e67df4c-edbf-4df1-903f-4fa25e1e71952020-06-10WarningsExact identifier
spl id: 83f35c81-93cb-4307-8f6b-1484d9c5d1b4
spl set id: 2e67df4c-edbf-4df1-903f-4fa25e1e7195

Reported adverse events (FAERS/openFDA)#

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