FDA.reportPublic FDA data

75% ALCOHOL HAND SANITIZER

Manufacturer
PHOENYX DISTRIBUTING, LLC | Fortress Expert Co., Ltd
Effective date
2020-06-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:20

Label at a glance#

Product75% ALCOHOL HAND SANITIZER
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Wet hands thoroughly with product and rub completely Covering hands Allow to dry without wiping children under the age of 6 should use with adult supervision Not recommended for infants

Storage and handling

/

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Helps reduce bacea at pontentially can caus dsease

Helps prevent Cross contamination on contact

Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only

Flammable, Keep away from fire or flame

Do not use near eyesIn case of eye contact flush with water for 15 minutes

If imitation persists stop use of product and get medical attention

Keep out of reach of childrenIn case of accidental ingestion seek medical attention orcontact a poison contro center immediately

Do not use

OTC - DO NOT USE SECTION

  • Do not use in or near the eyes. In case of contact with eyes flush thoroughly with water for 15 minutes

OTC - WHEN USING SECTION

When using this product

Do not use in or near the eyes. In case of contact with eyes flush thoroughly with water

OTC - STOP USE SECTION

/

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. case of accidental ingestion seek medical attention orcontact a poison contro center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and rub completely Covering hands
Allow to dry without wiping
children under the age of 6 should use with adult supervision
Not recommended for infants

Other information

STORAGE AND HANDLING SECTION

/

Inactive ingredients

INACTIVE INGREDIENT SECTION

water(Aqua) Acryatesc10-30 Alkyl Acrylate Crosspoymer Aminomethyl Propanol

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122334455667788991010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79316-007-012021-07-23C16284748780-1c7ccaba7-1f95-fd44-e053-dadaa90aa01ba9081f78-930e-727d-e053-2a95a90a5b2b
79316-007-022021-07-23C16284748780-1c7ccaba7-1f95-fd44-e053-dadaa90aa01ba9081f78-930e-727d-e053-2a95a90a5b2b
79316-007-032021-07-23C16284748780-1c7ccaba7-1f95-fd44-e053-dadaa90aa01ba9081f78-930e-727d-e053-2a95a90a5b2b
79316-007-042021-07-23C16284748780-1c7ccaba7-1f95-fd44-e053-dadaa90aa01ba9081f78-930e-727d-e053-2a95a90a5b2b
79316-007-052021-07-23C16284748780-1c7ccaba7-1f95-fd44-e053-dadaa90aa01ba9081f78-930e-727d-e053-2a95a90a5b2b
79316-007-062021-07-23C16284748780-1c7ccaba7-1f95-fd44-e053-dadaa90aa01ba9081f78-930e-727d-e053-2a95a90a5b2b
79316-007-072021-07-23C16284748780-1c7ccaba7-1f95-fd44-e053-dadaa90aa01ba9081f78-930e-727d-e053-2a95a90a5b2b
79316-007-082021-07-23C16284748780-1c7ccaba7-1f95-fd44-e053-dadaa90aa01ba9081f78-930e-727d-e053-2a95a90a5b2b
79316-007-092021-07-23C16284748780-1c7ccaba7-1f95-fd44-e053-dadaa90aa01ba9081f78-930e-727d-e053-2a95a90a5b2b
79316-007-102021-07-23C16284748780-1c7ccaba7-1f95-fd44-e053-dadaa90aa01ba9081f78-930e-727d-e053-2a95a90a5b2b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79316-007-0175% ALCOHOL HAND SANITIZER50 mL in 1 BOTTLEGEL501
79316-007-0275% ALCOHOL HAND SANITIZER60 mL in 1 BOTTLEGEL601
79316-007-0375% ALCOHOL HAND SANITIZER100 mL in 1 BOTTLEGEL1001
79316-007-0475% ALCOHOL HAND SANITIZER250 mL in 1 BOTTLEGEL2501
79316-007-0575% ALCOHOL HAND SANITIZER300 mL in 1 BOTTLEGEL3001
79316-007-0675% ALCOHOL HAND SANITIZER480 mL in 1 BOTTLEGEL4801
79316-007-0775% ALCOHOL HAND SANITIZER500 mL in 1 BOTTLEGEL5001
79316-007-0875% ALCOHOL HAND SANITIZER750 mL in 1 BOTTLEGEL7501
79316-007-0975% ALCOHOL HAND SANITIZER950 mL in 1 BOTTLEGEL9501
79316-007-1075% ALCOHOL HAND SANITIZER2000 mL in 1 BOTTLEGEL20001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79316-00775% ALCOHOL HAND SANITIZER GEL [PHOENYX DISTRIBUTING, LLC]1Legacy NDC, 10 package rows20200628_a9081f78-930e-727d-e053-2a95a90a5b2b.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79316-00779316-007-08, 79316-007-06, 79316-007-07, 79316-007-05, 79316-007-04, 79316-007-02, 79316-007-09, 79316-007-01, 79316-007-03, 79316-007-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMINOMETHYLPROPANOLLU49E6626QIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT

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
a9081f78-930f-727d-e053-2a95a90a5b2ba9081f78-930e-727d-e053-2a95a90a5b2b2020-06-26WarningsExact identifier
spl id: a9081f78-930f-727d-e053-2a95a90a5b2b
spl set id: a9081f78-930e-727d-e053-2a95a90a5b2b

Reported adverse events (FAERS/openFDA)#

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