Instant Hand Sanitizer

Manufacturer
Global Protection USA, Inc. | Safetec of America, Inc.
Effective date
2010-01-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:23:14

Label at a glance#

ProductInstant Hand Sanitizer
Active ingredientAlcohol
Label structure7 sections

Indications and uses

for handwashing to decrease bacteria on skin without soap and water recommended for repeated use

Dosage and administration

wet hands thoroughly with product allow to dry without wiping children under 6 should be supervised while using this product

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 66.5%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • for handwashing to decrease bacteria on skin without soap and water
  • recommended for repeated use

Warnings

WARNINGS SECTION

For external use only

Flammable, keep away from fire or flame

OTC - DO NOT USE SECTION

Do not use in the eyes. If this happens, rinse thoroughly with water

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If ingested get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • wet hands thoroughly with product
  • allow to dry without wiping
  • children under 6 should be supervised while using this product

INACTIVE INGREDIENT SECTION

Inactive ingredients aloe vera, carbomer, D&C green #5, D&C yellow #10, fragrance, purified water, triethanolamine

Distributed by
Global Protection USA, Inc.
West Berlin, NJ 08091
800-957-8955

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – BOTTLE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Global Protection, Inc. “Provider of Homeland Security Equipment”

Instant Hand Sanitizer

Kills 99.9% of Germs

Enriched with Aloe Vera

2 Fl. oz. (59ML)

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – BOTTLE
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – BOTTLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616762ethanol 66.5 % Topical GelPSN2
616762ethanol 0.665 ML/ML Topical GelSCD2
616762ethanol 66.5 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50225-355-012020-01-31C16284748780-19d75b9d0-84fa-f424-e053-dadaa90a57ceInstant Hand Sanitizer
50225-355-022020-01-31C16284748780-19d75b9d0-84fa-f424-e053-dadaa90a57ceInstant Hand Sanitizer
50225-355-032020-01-31C16284748780-19d75b9d0-84fa-f424-e053-dadaa90a57ceInstant Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50225-355-01Instant Hand Sanitizer59 mL in 1 BOTTLEGEL592
50225-355-02Instant Hand Sanitizer236 mL in 1 BOTTLEGEL2362
50225-355-03Instant Hand Sanitizer473 mL in 1 BOTTLEGEL4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50225-355INSTANT HAND SANITIZER GEL [GLOBAL PROTECTION USA, INC.]2Legacy NDC, 3 package rows20100116_aa6ab811-2ff3-45aa-aabf-33580b03bf59.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AlcoholACTIVE INGREDIENT3K9958V90M2
AlcoholACTIVE MOIETY3K9958V90M2
AloeINACTIVE INGREDIENTV5VD430YW92
D&C Green no. 5INACTIVE INGREDIENT8J6RDU8L9X2
D&C Yellow no. 10INACTIVE INGREDIENT35SW5USQ3G2
waterINACTIVE INGREDIENT059QF0KO0R2

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
50225-35550225-355-01, 50225-355-02, 50225-355-03

Ingredients#

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

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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 37 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, LIQUID FILLED / ORAL1.51 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C Green no. 5D&C GREEN NO. 58J6RDU8L9XSOAP / TOPICALNAExact identifier — unii candidate
6 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / SUBLINGUAL0.23 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C Green no. 5D&C GREEN NO. 58J6RDU8L9XTABLET, COATED / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GGUM, CHEWING / ORAL2 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GGEL / DENTALNAExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C Green no. 5D&C GREEN NO. 58J6RDU8L9XTABLET / ORAL0.03 mgExact identifier — unii candidate
6 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GGEL / TOPICALNAExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GSUSPENSION / ORAL20 mg/5mlExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GSUPPOSITORY / RECTAL0.11 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / ORAL80 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GSOLUTION / ORAL8 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C Green no. 5D&C GREEN NO. 58J6RDU8L9XSHAMPOO / TOPICAL0.09 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, EXTENDED RELEASE / ORAL14 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GPOWDER, FOR SUSPENSION / ORAL76 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GSHAMPOO / TOPICALNAExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GGUM, CHEWING / BUCCAL24 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GPASTE / DENTALNAExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GSOAP / TOPICAL1.4 %w/wExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GPOWDER / ORAL48 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, COATED / ORAL2.5 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GSUSPENSION, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GSOLUTION / RECTALNAExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GCONCENTRATE / ORAL0.03 mg/1mlExact identifier — unii candidate
31 equally ranked IID candidates
D&C Green no. 5D&C GREEN NO. 58J6RDU8L9XCAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, EXTENDED RELEASE / ORAL3 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GSYRUP / ORAL4 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, CHEWABLE / ORAL4 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GLOTION / TOPICALNAExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE / ORAL20 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, COATED PELLETS / ORAL0.01 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C Green no. 5D&C GREEN NO. 58J6RDU8L9XSOLUTION / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, DELAYED RELEASE / ORAL1.9 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, FILM COATED / ORAL120 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow no. 10D&C YELLOW NO. 1035SW5USQ3GELIXIR / ORAL0.3 mg/15mlExact identifier — unii candidate
31 equally ranked IID candidates

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
f9ca8878-77e5-4644-965f-e4b75ac6fa34aa6ab811-2ff3-45aa-aabf-33580b03bf592010-01-06WarningsExact identifier
spl id: f9ca8878-77e5-4644-965f-e4b75ac6fa34
spl set id: aa6ab811-2ff3-45aa-aabf-33580b03bf59

Reported adverse events (FAERS/openFDA)#

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