FDA.reportPublic FDA data

Phoenix Hand Sanitizer

Manufacturer
Phoenix Mcbs Llc | Shotwell Hydrogenics, LLC
Effective date
2020-04-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:07:33

Label at a glance#

ProductPhoenix Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

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

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or 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 15-30C(59-86F)
•        Avoid freezing and excessive heat above 40C(104F)

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, carbomer, deionized water, triethanolamine

SPL UNCLASSIFIED SECTION

Distributed By
Phoenix Protective Coatings
804 Summer Park Drive Ste. 450
Stafford, Texas 77477

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN2
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD2
808520isopropyl alcohol 70 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75547-905-022022-01-28C16284748780-1d6a99b39-a3f4-a426-e053-dadaa90af4c2Phoenix Hand Sanitizer
75547-905-082022-01-28C16284748780-1d6a99b39-a3f4-a426-e053-dadaa90af4c2Phoenix Hand Sanitizer
75547-905-102022-01-28C16284748780-1d6a99b39-a3f4-a426-e053-dadaa90af4c2Phoenix Hand Sanitizer
75547-905-162022-01-28C16284748780-1d6a99b39-a3f4-a426-e053-dadaa90af4c2Phoenix Hand Sanitizer
75547-905-322022-01-28C16284748780-1d6a99b39-a3f4-a426-e053-dadaa90af4c2Phoenix Hand Sanitizer
75547-905-642022-01-28C16284748780-1d6a99b39-a3f4-a426-e053-dadaa90af4c2Phoenix Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75547-905-02Phoenix Hand Sanitizer59 mL in 1 BOTTLELIQUID592
75547-905-08Phoenix Hand Sanitizer237 mL in 1 BOTTLELIQUID2372
75547-905-10Phoenix Hand Sanitizer3785 mL in 1 BOTTLELIQUID37852
75547-905-16Phoenix Hand Sanitizer473 mL in 1 BOTTLELIQUID4732
75547-905-32Phoenix Hand Sanitizer946 mL in 1 BOTTLELIQUID9462
75547-905-64Phoenix Hand Sanitizer1893 mL in 1 BOTTLELIQUID18932

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75547-905PHOENIX HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [PHOENIX MCBS LLC]2Legacy NDC, 6 package rows20200423_dc3d506d-23b4-4693-8cb1-53f0d7e47ad2.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
75547-90575547-905-02, 75547-905-08, 75547-905-16, 75547-905-32, 75547-905-64, 75547-905-10

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
ISOPROPYL ALCOHOLND2M416302ACTIB
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT

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
b8da63b7-9092-456c-b8cb-5db368e91c42dc3d506d-23b4-4693-8cb1-53f0d7e47ad22020-04-22WarningsExact identifier
spl id: b8da63b7-9092-456c-b8cb-5db368e91c42
spl set id: dc3d506d-23b4-4693-8cb1-53f0d7e47ad2

Reported adverse events (FAERS/openFDA)#

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