FDA.reportPublic FDA data

Pure Solutions Hand Sanitizer

Manufacturer
Urban Attitudes Holdings Ltd
Effective date
2020-05-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:34

Label at a glance#

ProductPure Solutions Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Storage and handling

Other information store between 15-30°C (59-86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Alcohol 76%

OTC - PURPOSE SECTION

Purpose
Antiseptic

INDICATIONS & USAGE SECTION

Uses

  • to decrease bacteria on the skin
  • recommended for repeated use

WARNINGS SECTION

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

OTC - WHEN USING SECTION

When using this product keep away from eyes. In case of eye contact, rinse eyes with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develop or last 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 immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

  • apply liberally to hands to cover all surfaces
  • rub hands together until dry
  • supervise children under 6 years old
  • not recommended for infants

STORAGE AND HANDLING SECTION

Other information

store between 15-30°C (59-86°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

glycerin, hydroxyethylcellulose, sodium hydroxide, water

SPL UNCLASSIFIED SECTION

Pure Solutions is a registered trademark of Urban Attitudes Holdings Ltd.

Distributed by:

Urban Attititudes Holdings Ltd.

Great Neck, NY 11023

(516) 206-3672

Made in Peru

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

puresolutions

HAND SANITIZER

Refreshing Gel

KILLS 99% GO GERMS AND BACTERIA ON CONTACT.

18 FL OZ (530 mL)

Blue Cap BottleBlue Cap Bottle

Blue Cap Bottle BackBlue Cap Bottle Back

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

puresolutions

HAND SANITIZER

Refreshing Gel

KILLS 99% OF GERMS AND BACTERIA ON CONTACT.

12 FL OZ (355 mL)

Yellow Cap Bottle FrontYellow Cap Bottle Front

Yellow Cap Bottle BackYellow Cap Bottle Back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1535597ethanol 76 % Topical GelPSN1
1535597ethanol 0.76 ML/ML Topical GelSCD1
1535597ethanol 76 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77185-001-012022-01-28C16284748780-1d6a99b39-7149-a426-e053-dadaa90af4c2Pure Solutions Hand Sanitizer
77185-001-022022-01-28C16284748780-1d6a99b39-7149-a426-e053-dadaa90af4c2Pure Solutions Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77185-001-01Pure Solutions Hand Sanitizer530 mL in 1 BOTTLE, PLASTICLIQUID5301
77185-001-02Pure Solutions Hand Sanitizer335 mL in 1 BOTTLE, PLASTICLIQUID3351

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77185-001PURE SOLUTIONS HAND SANITIZER (ETHANOL) LIQUID [URBAN ATTITUDES HOLDINGS LTD]1Legacy NDC, 2 package rows20200505_a4aed740-4116-327f-e053-2995a90a2214.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
77185-00177185-001-02, 77185-001-01

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
SODIUM HYDROXIDE55X04QC32IIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML · Source PDF

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
a4aed740-4115-327f-e053-2995a90a2214a4aed740-4116-327f-e053-2995a90a22142020-05-02WarningsExact identifier
spl id: a4aed740-4115-327f-e053-2995a90a2214
spl set id: a4aed740-4116-327f-e053-2995a90a2214

Reported adverse events (FAERS/openFDA)#

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