FDA.reportPublic FDA data

Soho Fresh Hand Sanitizer

Manufacturer
ESSAAR INC.
Effective date
2020-06-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:18:19

Label at a glance#

ProductSoho Fresh Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Dosage and administration

Thoroughly cover your hands with product and allow to dry without wiping. Children under 6 years of age should be supervised when using this product. Not recommended for infants.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only: hands. Flammable, Keep away from fire of flame.

When using this product

OTC - WHEN USING SECTION

Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Irritation or redness develops. Condition persist for more than 72 hours.

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

Thoroughly cover your hands with product and allow to dry without wiping. Children under 6 years of age should be supervised when using this product. Not recommended for infants.

Other information

SPL UNCLASSIFIED SECTION

Store below 105°F. May discolor some fabrics. Harmful to wood finishes and plastics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, propylene glycol, carbomer, triethanolamine.

Package Labeling: 60ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling: 250ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling: 500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

Package Labeling: 1000ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

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
78533-000-022022-01-28C16284748780-1d6a99b39-c2a9-a426-e053-dadaa90af4c2Soho Fresh Hand Sanitizer
78533-000-082022-01-28C16284748780-1d6a99b39-c2a9-a426-e053-dadaa90af4c2Soho Fresh Hand Sanitizer
78533-000-162022-01-28C16284748780-1d6a99b39-c2a9-a426-e053-dadaa90af4c2Soho Fresh Hand Sanitizer
78533-000-332022-01-28C16284748780-1d6a99b39-c2a9-a426-e053-dadaa90af4c2Soho Fresh Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78533-000-02Soho Fresh Hand Sanitizer60 mL in 1 BOTTLEGEL601
78533-000-08Soho Fresh Hand Sanitizer250 mL in 1 BOTTLEGEL2501
78533-000-16Soho Fresh Hand Sanitizer500 mL in 1 BOTTLEGEL5001
78533-000-33Soho Fresh Hand Sanitizer1000 mL in 1 BOTTLEGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78533-000SOHO FRESH HAND SANITIZER (ALCOHOL) GEL [ESSAAR INC.]1Legacy NDC, 4 package rows20200619_a85d6aad-046e-1994-e053-2995a90a87d8.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78533-00078533-000-02, 78533-000-08, 78533-000-16, 78533-000-33

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
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
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
a85d93b2-df81-d90d-e053-2a95a90a7bb5a85d6aad-046e-1994-e053-2995a90a87d82020-06-18WarningsExact identifier
spl id: a85d93b2-df81-d90d-e053-2a95a90a7bb5
spl set id: a85d6aad-046e-1994-e053-2995a90a87d8

Reported adverse events (FAERS/openFDA)#

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