FDA.reportPublic FDA data

Crown Solutions Instant Hand Sanitizer Gel

Manufacturer
RAF, LLC
Effective date
2021-09-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:42:25

Label at a glance#

ProductCrown Solutions Instant Hand Sanitizer Gel
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

Hand sanitizer to reduce bacteria on the skin

Dosage and administration

Apply a small amount unto hands, rub in hands thoroughly until dry. No rinsing required

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62% (v/v)

PURPOSE

OTC - PURPOSE SECTION

Antibacterial

USES:

INDICATIONS & USAGE SECTION

Hand sanitizer to reduce bacteria on the skin

WARNINGS:

WARNINGS SECTION

For external use only 

Flammable: Keep away from fire or flame

when using this product.

OTC - WHEN USING SECTION

Avoid contact with eyes. In case of eye contact, flush with water.

Stop use and if

OTC - STOP USE SECTION

irritation and redness develop and persist for more than 3 days.

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Apply a small amount unto hands, rub in hands thoroughly until dry. No rinsing required

OTHER INFORMATION :

SPL UNCLASSIFIED SECTION

Do not store above 120 degrees F

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

water, acrylates/SC 10-30 cross polymer, glycerin, propylene glycol, aloe barbadensis leaf juice, ammomethyl propanol, fragrance 

Package Labeling: 118 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

boxbox

Package Labeling: 236 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

boxbox

Package Labeling: 946 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

boxbox

Package Labeling: 3784 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle4Bottle4

boxbox

Package Labeling: 946000 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle5Bottle5

boxbox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN1
581660ethanol 0.62 ML/ML Topical GelSCD1
581660ethanol 62 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81570-001-012023-01-30C16284748780-1f386c64a-453a-0266-e053-dadaa90a7c1aCrown Solutions Instant Hand Sanitizer Gel
81570-001-022023-01-30C16284748780-1f386c64a-453a-0266-e053-dadaa90a7c1aCrown Solutions Instant Hand Sanitizer Gel
81570-001-032023-01-30C16284748780-1f386c64a-453a-0266-e053-dadaa90a7c1aCrown Solutions Instant Hand Sanitizer Gel
81570-001-042023-01-30C16284748780-1f386c64a-453a-0266-e053-dadaa90a7c1aCrown Solutions Instant Hand Sanitizer Gel
81570-001-052023-01-30C16284748780-1f386c64a-453a-0266-e053-dadaa90a7c1aCrown Solutions Instant Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81570-001-01Crown Solutions Instant Hand Sanitizer Gel24 in 1 BOXGEL241
81570-001-01Crown Solutions Instant Hand Sanitizer Gel118 mL in 1 BOTTLEGEL1181
81570-001-02Crown Solutions Instant Hand Sanitizer Gel236 mL in 1 BOTTLEGEL2361
81570-001-02Crown Solutions Instant Hand Sanitizer Gel24 in 1 BOXGEL241
81570-001-03Crown Solutions Instant Hand Sanitizer Gel4 in 1 BOXGEL41
81570-001-03Crown Solutions Instant Hand Sanitizer Gel946 mL in 1 BOTTLEGEL9461
81570-001-04Crown Solutions Instant Hand Sanitizer Gel3784 mL in 1 BOTTLEGEL37841
81570-001-04Crown Solutions Instant Hand Sanitizer Gel4 in 1 BOXGEL41
81570-001-05Crown Solutions Instant Hand Sanitizer Gel946000 mL in 1 TANKGEL9460001
81570-001-05Crown Solutions Instant Hand Sanitizer Gel1 in 1 BOXGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81570-001CROWN SOLUTIONS INSTANT HAND SANITIZER GEL (ALCOHOL) GEL [RAF, LLC]1Legacy NDC, 10 package rows20210918_0403be03-d72e-4ec5-8fd8-0a0deb9cefbf.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
81570-00181570-001-01, 81570-001-02, 81570-001-03, 81570-001-04, 81570-001-05

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
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
cbf7e393-eb90-b854-e053-2a95a90a9e0e0403be03-d72e-4ec5-8fd8-0a0deb9cefbf2021-09-14WarningsExact identifier
spl id: cbf7e393-eb90-b854-e053-2a95a90a9e0e
spl set id: 0403be03-d72e-4ec5-8fd8-0a0deb9cefbf

Reported adverse events (FAERS/openFDA)#

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