FDA.reportPublic FDA data

Freshorize Gel Hand Sanitizer

Manufacturer
Freshorize LTD | Freshorize LLC
Effective date
2021-03-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:04

Label at a glance#

ProductEthyl Alcohol
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

To decrease bacteria on the skin.

Dosage and administration

Apply small amount ot hands and rub lightly until dry. Supervise children in the use of the product.

Label contents#

Full prescribing information#

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycertin, Carbomer, Propylene Glycol, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate

Directions

INSTRUCTIONS FOR USE SECTION

Apply small amount ot hands and rub lightly until dry.

Supervise children in the use of the product.

Warnings:

WARNINGS SECTION

Flammable. Keep away from fire or flames. For external use only.
Keep out of reach of children.
Avoid contact with eyes.
In case of contact, rinse eyes throroughly with water.
Stop use and ask a doctor if skin irritation develops.
If ingested, get medical help or contact a
Poison Control Centre immediatly.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Other Information

OTHER SAFETY INFORMATION

Avoid extreme temperatures.

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin.

Front Label area

DOSAGE & ADMINISTRATION SECTION

Requires no water or towels.
Apply small amount to hands and rub lightly until dry.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

300 ml Hand Sanitizer300 ml Hand Sanitizer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52305-001-302023-01-30C16284748780-1f386c64a-4175-0266-e053-dadaa90a7c1aFreshorize Gel Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52305-001-30Ethyl Alcohol300 mL in 1 BOTTLE, PUMPGEL3001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52305-001ETHYL ALCOHOL (ALCOHOL) GEL [FRESHORIZE LTD]1Legacy NDC, 1 package rows20210319_bdc16d64-a0e1-4260-e053-2a95a90a6117.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52305-00152305-001-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER 934Z135WT9208IACT
ALCOHOL3K9958V90MACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT

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
bdc16d64-a0e2-4260-e053-2a95a90a6117bdc16d64-a0e1-4260-e053-2a95a90a61172021-03-17WarningsExact identifier
spl id: bdc16d64-a0e2-4260-e053-2a95a90a6117
spl set id: bdc16d64-a0e1-4260-e053-2a95a90a6117

Reported adverse events (FAERS/openFDA)#

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