FDA.reportPublic FDA data

Physicians Group Hand Sanitizer

Manufacturer
Physicians Group, L.L.C.
Effective date
2023-12-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:05:51

Label at a glance#

ProductPhysicians Group Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75% 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 availble.

Warnings

WARNINGS SECTION

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

Do not use:

OTC - DO NOT USE SECTION

  • on children less than 2 months of age
  • on open skin wounds
When using this product

OTC - WHEN USING SECTION

Keep out of eyes, ears and mouth. In case of contact with eyes rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Contol Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Package Labeling: 120ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

Package Labeling: 237ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

Package Labeling: 473ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Package Labeling: 3785ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle5Bottle5

Package Labeling : 59ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1047755ethanol 75 % Topical SolutionPSN4
1047755ethanol 0.75 ML/ML Topical SolutionSCD4
1047755ethanol 75 % Topical SolutionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77808-001-012025-01-30C16284748780-12cef2736-81fb-d83d-e063-dadaa90ab31fPhysicians Group Hand Sanitizer
77808-001-022025-01-30C16284748780-12cef2736-81fb-d83d-e063-dadaa90ab31fPhysicians Group Hand Sanitizer
77808-001-032025-01-30C16284748780-12cef2736-81fb-d83d-e063-dadaa90ab31fPhysicians Group Hand Sanitizer
77808-001-042025-01-30C16284748780-12cef2736-81fb-d83d-e063-dadaa90ab31fPhysicians Group Hand Sanitizer
77808-001-052025-01-30C16284748780-12cef2736-81fb-d83d-e063-dadaa90ab31fPhysicians Group Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77808-001-01Physicians Group Hand Sanitizer59 mL in 1 BOTTLELIQUID594
77808-001-02Physicians Group Hand Sanitizer120 mL in 1 BOTTLELIQUID1204
77808-001-03Physicians Group Hand Sanitizer237 mL in 1 BOTTLELIQUID2374
77808-001-04Physicians Group Hand Sanitizer473 mL in 1 BOTTLELIQUID4734
77808-001-05Physicians Group Hand Sanitizer3785 mL in 1 BOTTLELIQUID37854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77808-001PHYSICIANS GROUP HAND SANITIZER (ALCOHOL) LIQUID [PHYSICIANS GROUP, L.L.C.]4Legacy NDC, 5 package rows20231228_d2b7bf6b-4032-4516-8b5d-1f751ae3cee7.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
77808-00177808-001-01, 77808-001-02, 77808-001-03, 77808-001-04, 77808-001-05

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
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML · Source PDF

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
0d7e6cd9-85d5-5a42-e063-6394a90acb4fd2b7bf6b-4032-4516-8b5d-1f751ae3cee72023-12-27WarningsExact identifier
spl id: 0d7e6cd9-85d5-5a42-e063-6394a90acb4f
spl set id: d2b7bf6b-4032-4516-8b5d-1f751ae3cee7

Reported adverse events (FAERS/openFDA)#

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