FDA.reportPublic FDA data

Pulezza Instant Hand Sanitizer

Manufacturer
Tastek LLC
Effective date
2020-07-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:21:39

Label at a glance#

ProductPulezza Instant Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Label contents#

Full prescribing information#

Active ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Ethyl 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

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor 

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact  a Poison Control Center right away.

Directinos

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

SPL UNCLASSIFIED SECTION

  • Store between 15-30 °C (59-86°F)
  • Avoid freezing and excessive heat above 40 °C (104°F)
  • May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Glycerin, Propylene Glycol,Acrylates/C10-30 Alkyl Acrylate crosspolymer, Triethanoamine, Fragrance, Tocopheryl Acetate.

Package Labeling: 59ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label1Label1

Package Labeling: 236ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling: 500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling: 991ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN2
1305100ethanol 0.75 ML/ML Topical GelSCD2
1305100ethanol 75 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78702-000-022025-01-30C16284748780-12cef2736-6925-d83d-e063-dadaa90ab31fPulezza Instant Hand Sanitizer
78702-000-082025-01-30C16284748780-12cef2736-6925-d83d-e063-dadaa90ab31fPulezza Instant Hand Sanitizer
78702-000-162025-01-30C16284748780-12cef2736-6925-d83d-e063-dadaa90ab31fPulezza Instant Hand Sanitizer
78702-000-332025-01-30C16284748780-12cef2736-6925-d83d-e063-dadaa90ab31fPulezza Instant Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78702-000-02Pulezza Instant Hand Sanitizer59 mL in 1 BOTTLEGEL592
78702-000-08Pulezza Instant Hand Sanitizer236 mL in 1 BOTTLEGEL2362
78702-000-16Pulezza Instant Hand Sanitizer500 mL in 1 BOTTLEGEL5002
78702-000-33Pulezza Instant Hand Sanitizer991 mL in 1 BOTTLEGEL9912

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78702-000PULEZZA INSTANT HAND SANITIZER (ALCOHOL) GEL [TASTEK LLC]2Legacy NDC, 4 package rows20200717_a8edbbb5-7ddc-86d3-e053-2995a90a9f51.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78702-00078702-000-02, 78702-000-08, 78702-000-16, 78702-000-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
MALTODEXTRIN7CVR7L4A2DIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALCOHOL3K9958V90MACTIB

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
aa94426d-eac8-3df0-e053-2a95a90ab8d3a8edbbb5-7ddc-86d3-e053-2995a90a9f512020-07-16WarningsExact identifier
spl id: aa94426d-eac8-3df0-e053-2a95a90ab8d3
spl set id: a8edbbb5-7ddc-86d3-e053-2995a90a9f51

Reported adverse events (FAERS/openFDA)#

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