FDA.reportPublic FDA data

Hand Sanitizer - ProStat First Aid | Trifecta Pharmaceuticals USA LLC

Manufacturer
ProStat First Aid | Trifecta Pharmaceuticals USA LLC
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:52:16

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

For hand sanitizing to decrease bacteria on skin without soap and water

Dosage and administration

Put enough product on your palm to cover hands and briskly rub hands together until dry. For children under 6 years old use only under adult supervision

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 62% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For hand sanitizing to decrease bacteria on skin without soap and water

Warnings

WARNINGS SECTION

  • for external use only
  • Use with caution if allergic to alcohol.
  • Flammable. Keep away from heat or flames.

Do not use

OTC - DO NOT USE SECTION

Do not Use

  • in the eyes

Directions

DOSAGE & ADMINISTRATION SECTION

Put enough product on your palm to cover hands and briskly rub hands together until dry.

For children under 6 years old use only under adult supervision

Keep out of reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact poison control center immediately.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, Acrylates/C10-30 alkyl acrylate crosspolymer, Fragrance, Glycerin, Maltodextrin, Propylene glycol, Tocopheryl acetate, Triethanoamine, water.

Other Information

SPL UNCLASSIFIED SECTION

  • Do not store above 105°F
  • May discolor some fabrics
  • Harmful to wood finishes and plastic

Questions

OTC - QUESTIONS SECTION

Questions

Call 1-888-900-2920

M-F 8AM - 4PM PST

Other Information

SPL UNCLASSIFIED SECTION

Distributed by

ProStat First Aid LLC

La Verne, CA 91750

Part No. 2362

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3151_TRI_HAND SANITIZER_0.9G_PACKET_012726 CDER3151_TRI_HAND SANITIZER_0.9G_PACKET_012726 CDER

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58228-7200-1Hand Sanitizer2000 in 1 BAGGEL20001
58228-7200-1Hand Sanitizer0.9 g in 1 PACKETGEL0.91

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
58228-720058228-7200-1

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
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
TROLAMINE9O3K93S3TKIACT
FRAGRANCE 135765EM498GW35IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MALTODEXTRIN7CVR7L4A2DIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
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
Hand SanitizerALCOHOLProStat First Aid4e54aecb-190f-3866-e063-6294a90a810a2026-03-31WarningsExact identifier
ndc (package): 58228-7200-1
ndc (product): 58228-7200
ndc11 (package): 58228720001
spl id: 4e54ac54-31fa-8d33-e063-6394a90a2ef5
spl set id: 4e54aecb-190f-3866-e063-6294a90a810a

Reported adverse events (FAERS/openFDA)#

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