FDA.reportPublic FDA data

Protector Brands Hand Sanitizer

Manufacturer
Raining Rose, Inc.
Effective date
2020-04-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:06:07

Label at a glance#

ProductProtector Brands Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Ethyl Alcohol 64%

OTC - PURPOSE SECTION

Purpose

Antimicrobial

INDICATIONS & USAGE SECTION

Uses
• Hand Sanitizer to help reduce bacteria on the skin.
• Recommended for repeated use.

WARNINGS SECTION

Warnings• For external use only. • Flammable, keep away from fire
or flame • Do not use in eyes. In case of eye contact flush
thoroughly with water and seek medical attention. • Stop use and
ask doctor if irritation and redness develop and persists for more
than 72 hours.

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.

DOSAGE & ADMINISTRATION SECTION

Directions
• Dispense an adequate amount in your palm to cover all surfaces of hands completely.

• Rub hands together until dry. • Does not require rinsing.

OTHER SAFETY INFORMATION

Other Information
• Do not store above 100°F.
• May discolor some fabrics.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Glycerin, Carbomer

Diisopropylamine, Fragrance.

Principal Display Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Protector​TM​

HAND

SANITIZER

made with 64% ethyl alcohol

EFFECTIVE

        +

CLEAN-SCENTED

2 FL OZ. (59 ml)

Manufactured for: Protector Brands

100 30th Street Drive SE, Cedar Rapids, IA 52403

888-301-4820| www.protectorbrands.com

L341739

L341739 hand sani 2 oz 64L341739 hand sani 2 oz 64

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052526ethanol 64 % Topical GelPSN1
1052526ethanol 0.64 ML/ML Topical GelSCD1
1052526ethanol 64 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65692-2002-12023-01-30C16284748780-1f386c649-abd1-0266-e053-dadaa90a7c1aProtector Brands Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65692-2002-1Protector Brands Hand Sanitizer59 mL in 1 BOTTLE, PLASTICGEL591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65692-2002PROTECTOR BRANDS HAND SANITIZER (ETHYL ALCOHOL) GEL [RAINING ROSE, INC.]1Legacy NDC, 1 package rows20200414_9effb652-b093-4b87-b694-77e516b6d95c.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
65692-200265692-2002-1

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
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
DIISOPROPYLAMINEBR9JLI40NOIACT

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
04449c97-85b0-4840-9daa-d92a10361cef9effb652-b093-4b87-b694-77e516b6d95c2020-04-13WarningsExact identifier
spl id: 04449c97-85b0-4840-9daa-d92a10361cef
spl set id: 9effb652-b093-4b87-b694-77e516b6d95c

Reported adverse events (FAERS/openFDA)#

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