FDA.reportPublic FDA data

Prosera Soothing Hand Sanitizer

Manufacturer
D-Time Limited Liability Company
Effective date
2021-11-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:44:39

Label at a glance#

ProductProsera Soothing Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Adults and children over 2 years: ∙ For occasional and personal domestic use ∙ Supervise children when they use this product ∙ Spray onto hands and rub thoroughly for at least 30 seconds. Allow to dry.

Storage and handling

Store at 68 to 70 F (20 to 25 C). May discolor certain fabrics on surfaces

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic skin cleanser

Use

INDICATIONS & USAGE SECTION

For personal hand hygiene to help prevent the spread of bacteria

Warning

WARNINGS SECTION

For external use only
When using this product avoid contact with eyes.
Flammable. Keep away from heat and flame.

Ask doctor

OTC - ASK DOCTOR SECTION

Stop use and consult a healthcare professional if irritation develops.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, contact a Poison Control Center or , get medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 2 years: ∙ For occasional and personal domestic use ∙ Supervise children when they use this product ∙ Spray onto hands and rub thoroughly for at least 30 seconds. Allow to dry.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Isopropyl alcohol, Glycerin, Hyaluronic Acid, Allantoin, Vitamin E, Vetiver Oil, Sage Oil, Hydrogen Peroxide 

Other information

STORAGE AND HANDLING SECTION

Store at 68 to 70 F (20 to 25 C). May discolor certain fabrics on surfaces

Questions?

SPL UNCLASSIFIED SECTION

1-844-800-6858

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN2
1039339ethanol 0.8 ML/ML Topical SolutionSCD2
1039339ethanol 80 % Topical SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75306-004-012023-01-30C16284748780-1f386c649-dac2-0266-e053-dadaa90a7c1aProsera Soothing Hand Sanitizer
75306-004-022023-01-30C16284748780-1f386c649-dac2-0266-e053-dadaa90a7c1aProsera Soothing Hand Sanitizer
75306-004-032023-01-30C16284748780-1f386c649-dac2-0266-e053-dadaa90a7c1aProsera Soothing Hand Sanitizer
75306-004-042023-01-30C16284748780-1f386c649-dac2-0266-e053-dadaa90a7c1aProsera Soothing Hand Sanitizer
75306-004-052023-01-30C16284748780-1f386c649-dac2-0266-e053-dadaa90a7c1aProsera Soothing Hand Sanitizer
75306-004-062023-01-30C16284748780-1f386c649-dac2-0266-e053-dadaa90a7c1aProsera Soothing Hand Sanitizer
75306-004-072023-01-30C16284748780-1f386c649-dac2-0266-e053-dadaa90a7c1aProsera Soothing Hand Sanitizer
75306-004-082023-01-30C16284748780-1f386c649-dac2-0266-e053-dadaa90a7c1aProsera Soothing Hand Sanitizer
75306-004-092023-01-30C16284748780-1f386c649-dac2-0266-e053-dadaa90a7c1aProsera Soothing Hand Sanitizer
75306-004-102023-01-30C16284748780-1f386c649-dac2-0266-e053-dadaa90a7c1aProsera Soothing Hand Sanitizer
75306-004-112023-01-30C16284748780-1f386c649-dac2-0266-e053-dadaa90a7c1aProsera Soothing Hand Sanitizer
75306-004-122023-01-30C16284748780-1f386c649-dac2-0266-e053-dadaa90a7c1aProsera Soothing Hand Sanitizer
75306-004-132023-01-30C16284748780-1f386c649-dac2-0266-e053-dadaa90a7c1aProsera Soothing Hand Sanitizer
75306-004-142023-01-30C16284748780-1f386c649-dac2-0266-e053-dadaa90a7c1aProsera Soothing Hand Sanitizer
75306-004-152023-01-30C16284748780-1f386c649-dac2-0266-e053-dadaa90a7c1aProsera Soothing Hand Sanitizer
75306-004-162023-01-30C16284748780-1f386c649-dac2-0266-e053-dadaa90a7c1aProsera Soothing Hand Sanitizer
75306-004-172023-01-30C16284748780-1f386c649-dac2-0266-e053-dadaa90a7c1aProsera Soothing Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75306-004-01Prosera Soothing Hand Sanitizer30 mL in 1 BOTTLE, SPRAYLIQUID302
75306-004-02Prosera Soothing Hand Sanitizer50 mL in 1 BOTTLE, SPRAYLIQUID502
75306-004-03Prosera Soothing Hand Sanitizer60 mL in 1 BOTTLE, SPRAYLIQUID602
75306-004-04Prosera Soothing Hand Sanitizer100 mL in 1 BOTTLE, SPRAYLIQUID1002
75306-004-05Prosera Soothing Hand Sanitizer120 mL in 1 BOTTLE, SPRAYLIQUID1202
75306-004-06Prosera Soothing Hand Sanitizer150 mL in 1 BOTTLE, SPRAYLIQUID1502
75306-004-07Prosera Soothing Hand Sanitizer160 mL in 1 BOTTLE, SPRAYLIQUID1602
75306-004-08Prosera Soothing Hand Sanitizer200 mL in 1 BOTTLE, SPRAYLIQUID2002
75306-004-09Prosera Soothing Hand Sanitizer250 mL in 1 BOTTLE, SPRAYLIQUID2502
75306-004-10Prosera Soothing Hand Sanitizer500 mL in 1 BOTTLE, SPRAYLIQUID5002
75306-004-11Prosera Soothing Hand Sanitizer1000 mL in 1 BOTTLE, SPRAYLIQUID10002
75306-004-12Prosera Soothing Hand Sanitizer3785 mL in 1 BOTTLE, SPRAYLIQUID37852
75306-004-13Prosera Soothing Hand Sanitizer18927 mL in 1 BOTTLE, SPRAYLIQUID189272
75306-004-14Prosera Soothing Hand Sanitizer5000 mL in 1 BOTTLE, SPRAYLIQUID50002
75306-004-15Prosera Soothing Hand Sanitizer10000 mL in 1 BOTTLE, SPRAYLIQUID100002
75306-004-16Prosera Soothing Hand Sanitizer15000 mL in 1 BOTTLE, SPRAYLIQUID150002
75306-004-17Prosera Soothing Hand Sanitizer20000 mL in 1 BOTTLE, SPRAYLIQUID200002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75306-004PROSERA SOOTHING HAND SANITIZER (ALCOHOL) LIQUID [D-TIME LIMITED LIABILITY COMPANY]2Legacy NDC, 17 package rows20211103_67f9fb4c-b07a-4af0-a66e-24e34e16d7dc.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75306-00475306-004-01, 75306-004-02, 75306-004-03, 75306-004-04, 75306-004-05, 75306-004-06, 75306-004-07, 75306-004-08, 75306-004-09, 75306-004-10, 75306-004-11, 75306-004-12, 75306-004-13, 75306-004-14, 75306-004-15, 75306-004-16, 75306-004-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
HYALURONIC ACIDS270N0TRQYIACT
ALLANTOIN344S277G0ZIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
VETIVER OIL9M9P32M01LIACT
SAGE OILU27K0H1H2OIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
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
cfd1205b-d005-0c3c-e053-2a95a90a4e1267f9fb4c-b07a-4af0-a66e-24e34e16d7dc2021-11-02WarningsExact identifier
spl id: cfd1205b-d005-0c3c-e053-2a95a90a4e12
spl set id: 67f9fb4c-b07a-4af0-a66e-24e34e16d7dc

Reported adverse events (FAERS/openFDA)#

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