PRISTINE1

Manufacturer
Caribbean Spirit Imports LLC
Effective date
2020-06-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:15:37

Label at a glance#

ProductPRISTINE1
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Put enough product in your palm to cover hands and rub hands together briskly until dry. Children under 6 years of age should be supervised when using.

Storage and handling

STORE BELOW 110F. May discolor sorne fabrics and surfaces.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antimicrobial

activeactive

Purpose

OTC - PURPOSE SECTION

Antimicrobial purposepurpose, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on skin

UseUse

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

When using this product do not use in or near the eyes. In case of contact, flush thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts.

dont usedont use

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. In case of contact, flush thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts.

WhenWhen

OTC - STOP USE SECTION

When using this product do not use in or near the eyes. In case of contact, flush thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts.

stopstop

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.

keepkeep

Directions

DOSAGE & ADMINISTRATION SECTION

  • Put enough product in your palm to cover hands and rub hands together briskly until dry. Children under 6 years of age should be supervised when using.

dosagedosage

Other information

STORAGE AND HANDLING SECTION

  • STORE BELOW 110F. May discolor sorne fabrics and surfaces.
  • storagestorage

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, triethanolamine, Carbomer, Aloe vera extract, phenoxyethanol

inactiveinactive

RECENT MAJOR CHANGES SECTION

majormajor

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hand Sanitizer Gel with Aloe Vera

Kills 99.9% of Germs

frontfront

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77605-110-012022-01-28C16284748780-1d6a99b39-c1da-a426-e053-dadaa90af4c2a5dc6474-d439-0280-e053-2a95a90aca1b
77605-110-022022-01-28C16284748780-1d6a99b39-c1da-a426-e053-dadaa90af4c2a5dc6474-d439-0280-e053-2a95a90aca1b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77605-110-01PRISTINE1325 mL in 1 BOTTLE, PLASTICGEL3253
77605-110-02PRISTINE13785 mL in 1 BOTTLE, PLASTICGEL37853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77605-110PRISTINE1 (ALCOHOL) GEL [CARIBBEAN SPIRIT IMPORTS LLC]3Legacy NDC, 2 package rows20200602_a5dc6474-d439-0280-e053-2a95a90aca1b.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
77605-11077605-110-01, 77605-110-02

Ingredients#

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

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

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
a70a14c8-e63a-e80e-e053-2a95a90a5adca5dc6474-d439-0280-e053-2a95a90aca1b2020-06-01WarningsExact identifier
spl id: a70a14c8-e63a-e80e-e053-2a95a90a5adc
spl set id: a5dc6474-d439-0280-e053-2a95a90aca1b

Reported adverse events (FAERS/openFDA)#

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