FDA.reportPublic FDA data

PhlexSan

Manufacturer
GLOBAL CO PAK LLC | Four Fathers Distillery LLC
Effective date
2020-12-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:34:32

Label at a glance#

ProductPhlexSan Gel Alcohol Hand Sanitizer
Active ingredientALCOHOL
Label structure13 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#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

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

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

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 a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash 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 ingredients

INACTIVE INGREDIENT SECTION

glycerin, aloe, cellulose, thickener, essential oils, purified water USP

Package Label - Principal Display Panel PhlexSan 1 Gallon PhlexSan 16oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785 mL NDC: 80892-004-01

PhlexSan Gel 128oz.jpg

PhlexSan Gel 128ozPhlexSan Gel 128oz

473 mL NDC: 80892-004-16

PhlexSan Gel 16oz.jpg

PhlexSan Gel 16ozPhlexSan Gel 16oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80892-004-012022-01-28C16284748780-1d6a99b39-cd80-a426-e053-dadaa90af4c2b35e24db-ccfa-571c-e053-2995a90a9e30
80892-004-022022-01-28C16284748780-1d6a99b39-cd80-a426-e053-dadaa90af4c2b35e24db-ccfa-571c-e053-2995a90a9e30
80892-004-042022-01-28C16284748780-1d6a99b39-cd80-a426-e053-dadaa90af4c2b35e24db-ccfa-571c-e053-2995a90a9e30
80892-004-082022-01-28C16284748780-1d6a99b39-cd80-a426-e053-dadaa90af4c2b35e24db-ccfa-571c-e053-2995a90a9e30
80892-004-162022-01-28C16284748780-1d6a99b39-cd80-a426-e053-dadaa90af4c2b35e24db-ccfa-571c-e053-2995a90a9e30
80892-004-322022-01-28C16284748780-1d6a99b39-cd80-a426-e053-dadaa90af4c2b35e24db-ccfa-571c-e053-2995a90a9e30
80892-004-642022-01-28C16284748780-1d6a99b39-cd80-a426-e053-dadaa90af4c2b35e24db-ccfa-571c-e053-2995a90a9e30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80892-004-01PhlexSan Gel Alcohol Hand Sanitizer3785 mL in 1 BOTTLE, PUMPGEL37852
80892-004-02PhlexSan Gel Alcohol Hand Sanitizer60 mL in 1 BOTTLE, PUMPGEL602
80892-004-04PhlexSan Gel Alcohol Hand Sanitizer119 mL in 1 BOTTLE, PUMPGEL1192
80892-004-08PhlexSan Gel Alcohol Hand Sanitizer237 mL in 1 BOTTLE, PUMPGEL2372
80892-004-16PhlexSan Gel Alcohol Hand Sanitizer473 mL in 1 BOTTLE, PUMPGEL4732
80892-004-32PhlexSan Gel Alcohol Hand Sanitizer946 mL in 1 BOTTLE, PUMPGEL9462
80892-004-64PhlexSan Gel Alcohol Hand Sanitizer1892 mL in 1 BOTTLE, PUMPGEL18922

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80892-004PHLEXSAN GEL ALCOHOL HAND SANITIZER (ALCOHOL) GEL [GLOBAL CO PAK LLC]2Legacy NDC, 7 package rows20201203_b35e24db-ccfa-571c-e053-2995a90a9e30.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
80892-00480892-004-01, 80892-004-64, 80892-004-32, 80892-004-16, 80892-004-08, 80892-004-04, 80892-004-02

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
POWDERED CELLULOSESMD1X3XO9MIACT
GLYCERINPDC6A3C0OXIACT
ALOEV5VD430YW9IACT
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
b583a71c-f604-6d1a-e053-2a95a90a2342b35e24db-ccfa-571c-e053-2995a90a9e302020-12-02WarningsExact identifier
spl id: b583a71c-f604-6d1a-e053-2a95a90a2342
spl set id: b35e24db-ccfa-571c-e053-2995a90a9e30

Reported adverse events (FAERS/openFDA)#

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