FDA.reportPublic FDA data

PSR 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#

ProductPSR Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

For personal hand hygiene to help prevent the spread of bacteria.

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 80%

Purpose

OTC - PURPOSE SECTION

Antiseptic skin cleanser

Uses

INDICATIONS & USAGE SECTION

For personal hand hygiene to help prevent the spread of bacteria.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat and flame

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

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, get medical help or contact a Poison Control Center 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 (Aqua), Glycerin, Apricot kernel oil, Bergamot leaf oil, Hydrogen peroxide, Sodium pyruvate

Other information

Store at 68° to 70° F (20° to 25° C).
May discolor certain fabrics or surfaces.
Questions? 1-844-800-6858

Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
75306-009-012023-01-30C16284748780-1f386c64a-3339-0266-e053-dadaa90a7c1a6d7b95f9-214b-40fd-93c6-d4e1c420bdba
75306-009-022023-01-30C16284748780-1f386c64a-3339-0266-e053-dadaa90a7c1a6d7b95f9-214b-40fd-93c6-d4e1c420bdba
75306-009-032023-01-30C16284748780-1f386c64a-3339-0266-e053-dadaa90a7c1a6d7b95f9-214b-40fd-93c6-d4e1c420bdba
75306-009-042023-01-30C16284748780-1f386c64a-3339-0266-e053-dadaa90a7c1a6d7b95f9-214b-40fd-93c6-d4e1c420bdba
75306-009-052023-01-30C16284748780-1f386c64a-3339-0266-e053-dadaa90a7c1a6d7b95f9-214b-40fd-93c6-d4e1c420bdba
75306-009-062023-01-30C16284748780-1f386c64a-3339-0266-e053-dadaa90a7c1a6d7b95f9-214b-40fd-93c6-d4e1c420bdba
75306-009-072023-01-30C16284748780-1f386c64a-3339-0266-e053-dadaa90a7c1a6d7b95f9-214b-40fd-93c6-d4e1c420bdba
75306-009-082023-01-30C16284748780-1f386c64a-3339-0266-e053-dadaa90a7c1a6d7b95f9-214b-40fd-93c6-d4e1c420bdba
75306-009-092023-01-30C16284748780-1f386c64a-3339-0266-e053-dadaa90a7c1a6d7b95f9-214b-40fd-93c6-d4e1c420bdba
75306-009-102023-01-30C16284748780-1f386c64a-3339-0266-e053-dadaa90a7c1a6d7b95f9-214b-40fd-93c6-d4e1c420bdba
75306-009-112023-01-30C16284748780-1f386c64a-3339-0266-e053-dadaa90a7c1a6d7b95f9-214b-40fd-93c6-d4e1c420bdba
75306-009-122023-01-30C16284748780-1f386c64a-3339-0266-e053-dadaa90a7c1a6d7b95f9-214b-40fd-93c6-d4e1c420bdba
75306-009-132023-01-30C16284748780-1f386c64a-3339-0266-e053-dadaa90a7c1a6d7b95f9-214b-40fd-93c6-d4e1c420bdba
75306-009-142023-01-30C16284748780-1f386c64a-3339-0266-e053-dadaa90a7c1a6d7b95f9-214b-40fd-93c6-d4e1c420bdba
75306-009-152023-01-30C16284748780-1f386c64a-3339-0266-e053-dadaa90a7c1a6d7b95f9-214b-40fd-93c6-d4e1c420bdba
75306-009-162023-01-30C16284748780-1f386c64a-3339-0266-e053-dadaa90a7c1a6d7b95f9-214b-40fd-93c6-d4e1c420bdba
75306-009-172023-01-30C16284748780-1f386c64a-3339-0266-e053-dadaa90a7c1a6d7b95f9-214b-40fd-93c6-d4e1c420bdba

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75306-009-01PSR Hand Sanitizer30 mL in 1 BOTTLE, SPRAYSPRAY302
75306-009-02PSR Hand Sanitizer50 mL in 1 BOTTLE, SPRAYSPRAY502
75306-009-03PSR Hand Sanitizer60 mL in 1 BOTTLE, SPRAYSPRAY602
75306-009-04PSR Hand Sanitizer100 mL in 1 BOTTLE, SPRAYSPRAY1002
75306-009-05PSR Hand Sanitizer120 mL in 1 BOTTLE, SPRAYSPRAY1202
75306-009-06PSR Hand Sanitizer150 mL in 1 BOTTLE, SPRAYSPRAY1502
75306-009-07PSR Hand Sanitizer160 mL in 1 BOTTLE, SPRAYSPRAY1602
75306-009-08PSR Hand Sanitizer200 mL in 1 BOTTLE, SPRAYSPRAY2002
75306-009-09PSR Hand Sanitizer250 mL in 1 BOTTLE, SPRAYSPRAY2502
75306-009-10PSR Hand Sanitizer500 mL in 1 BOTTLE, SPRAYSPRAY5002
75306-009-11PSR Hand Sanitizer1000 mL in 1 BOTTLE, SPRAYSPRAY10002
75306-009-12PSR Hand Sanitizer3785 mL in 1 BOTTLE, SPRAYSPRAY37852
75306-009-13PSR Hand Sanitizer18927 mL in 1 BOTTLE, SPRAYSPRAY189272
75306-009-14PSR Hand Sanitizer5000 mL in 1 BOTTLE, SPRAYSPRAY50002
75306-009-15PSR Hand Sanitizer10000 mL in 1 BOTTLE, SPRAYSPRAY100002
75306-009-16PSR Hand Sanitizer15000 mL in 1 BOTTLE, SPRAYSPRAY150002
75306-009-17PSR Hand Sanitizer20000 mL in 1 BOTTLE, SPRAYSPRAY200002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75306-009PSR HAND SANITIZER (ETHYL ALCOHOL) SPRAY [D-TIME LIMITED LIABILITY COMPANY]2Legacy NDC, 17 package rows20211103_6d7b95f9-214b-40fd-93c6-d4e1c420bdba.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75306-00975306-009-01, 75306-009-02, 75306-009-03, 75306-009-04, 75306-009-05, 75306-009-06, 75306-009-07, 75306-009-08, 75306-009-09, 75306-009-10, 75306-009-11, 75306-009-12, 75306-009-13, 75306-009-14, 75306-009-15, 75306-009-16, 75306-009-17

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
APRICOT KERNEL OIL54JB35T06AIACT
BERGAMOT OIL39W1PKE3JIIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
SODIUM PYRUVATEPOD38AIF08IACT
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
cfd1375e-fdf1-18ac-e053-2995a90ae18a6d7b95f9-214b-40fd-93c6-d4e1c420bdba2021-11-02WarningsExact identifier
spl id: cfd1375e-fdf1-18ac-e053-2995a90ae18a
spl set id: 6d7b95f9-214b-40fd-93c6-d4e1c420bdba

Reported adverse events (FAERS/openFDA)#

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