FDA.reportPublic FDA data

PHx Hand Sanitizer

Manufacturer
Phx Hand Sanitizer Llc
Effective date
2020-09-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:52

Label at a glance#

ProductPHx Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

Indications and uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. Use when soap and water are not available.

Dosage and administration

• Place enough product on hands to cover all surfaces. Rub hands together until dry. • Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

• Store between 59-86˚F (15-30˚C) • Avoid freezing and excessive heat above 104˚F (40˚C)

Label contents#

Full prescribing information#

​Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol 70% v/v

​Purpose

OTC - PURPOSE SECTION

Antiseptic

​Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease. Use when soap and water are not available.

​Warnings

WARNINGS SECTION

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

​Do not use

• In children less than 2 months of age

• On open skin wounds

​When using this product ​keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

​Stop use and ask for a doctor ​if irritation occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

​Keep out of reach of children. ​If swallowed, get medical help or contact a Poison Control Center right away.

​Directions

DOSAGE & ADMINISTRATION SECTION

• Place enough product on hands to cover all surfaces. Rub hands together until dry.

• Supervise children under 6 years of age when using this product to avoid swallowing.

​Other information

STORAGE AND HANDLING SECTION

• Store between 59-86˚F (15-30˚C)

• Avoid freezing and excessive heat above 104˚F (40˚C)

INACTIVE INGREDIENT SECTION

Inactive Ingredients: deionized water, polyethylene glycol, AMP - acrylates/vinyl isodecanoate crosspolymer, aloe barbadensis

leaf juice, glycerin, tocopheryl acetate (vitamin E acetate)

SPL UNCLASSIFIED SECTION

70% ISOPROPYL ALCOHOL WITH ALOE AND VITAMIN E

www.phxhandsan.com

​MADE IN USA

​PHx Hand Sanitizer

804 Summer Park, Suite 450

Stafford, TX 77477

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

PackagingPackaging

PackagingPackaging

PackagingPackaging

PackagingPackaging

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581698isopropyl alcohol 70 % Topical GelPSN1
581698isopropyl alcohol 0.7 ML/ML Topical GelSCD1
581698isopropyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80304-100-022022-01-28C16284748780-1d6a99b39-94e1-a426-e053-dadaa90af4c2PH​x HAND SANITIZER
80304-100-042022-01-28C16284748780-1d6a99b39-94e1-a426-e053-dadaa90af4c2PH​x HAND SANITIZER
80304-100-082022-01-28C16284748780-1d6a99b39-94e1-a426-e053-dadaa90af4c2PH​x HAND SANITIZER
80304-100-162022-01-28C16284748780-1d6a99b39-94e1-a426-e053-dadaa90af4c2PH​x HAND SANITIZER
80304-100-282022-01-28C16284748780-1d6a99b39-94e1-a426-e053-dadaa90af4c2PH​x HAND SANITIZER
80304-100-322022-01-28C16284748780-1d6a99b39-94e1-a426-e053-dadaa90af4c2PH​x HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80304-100-02PHx Hand Sanitizer59 mL in 1 BOTTLE, PLASTICGEL591
80304-100-04PHx Hand Sanitizer118 mL in 1 BOTTLE, PLASTICGEL1181
80304-100-08PHx Hand Sanitizer237 mL in 1 BOTTLE, PLASTICGEL2371
80304-100-16PHx Hand Sanitizer475 mL in 1 BOTTLE, PLASTICGEL4751
80304-100-28PHx Hand Sanitizer3800 mL in 1 BOTTLE, PLASTICGEL38001
80304-100-32PHx Hand Sanitizer950 mL in 1 BOTTLE, PLASTICGEL9501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80304-100PHX HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [PHX HAND SANITIZER LLC]1Legacy NDC, 6 package rows20200904_eb8b3b44-8ccd-407c-8e9e-79a1a3012036.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
80304-10080304-100-02, 80304-100-04, 80304-100-08, 80304-100-16, 80304-100-32, 80304-100-28

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
ISOPROPYL ALCOHOLND2M416302ACTIB
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%)2N8MDB79NAIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
a746ea70-4de5-4651-a702-00f5db05cd63eb8b3b44-8ccd-407c-8e9e-79a1a30120362020-09-01WarningsExact identifier
spl id: a746ea70-4de5-4651-a702-00f5db05cd63
spl set id: eb8b3b44-8ccd-407c-8e9e-79a1a3012036

Reported adverse events (FAERS/openFDA)#

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