FDA.reportPublic FDA data

Hand Sanitizer Gel - Ethyl

Manufacturer
Atlanta Supersource, Inc.
Effective date
2022-12-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:52:04

Label at a glance#

ProductHand 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

Rinse-Free

Product Description: Help keep your family and those you care for healthy with Super Source Instant Hand Sanitizer. Keeping your hands clean and in good condition is one of the best ways to prevent illness. We know that life moves fast, and that washing your hands with soap and water is not always an option.

NDC: 75056-002-03 Produced in an FDA Registered Facility

Atlanta Supersource, Inc.

3655 Kennesaw 75 PKWY, Suite 100

Kennesaw, GA 30144

833.423.0006

EMERGENCY RESPONSE PROVIDED BY: Chemtrec 1.800.424.9300

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

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.

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

Methacrylic Acid - Ethyl Acrylate Copolymer (4500 MPA.S), Trolamine, Glycerin, Water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Net Contents: 1 Gallon (3.78L) mL NDC: 75053-003-01

full labelfull label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN4
581660ethanol 0.62 ML/ML Topical GelSCD4
581660ethanol 62 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75056-003-012024-01-30C16284748780-11030e365-5a58-111a-e063-dadaa90a10e2Hand Sanitizer Gel - Ethyl

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75056-003-01Hand Sanitizer3780 mL in 1 BOTTLE, PLASTICGEL37804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75056-003HAND SANITIZER (ALCOHOL) GEL [ATLANTA SUPERSOURCE, INC.]4Legacy NDC, 1 package rows20221206_a48404d6-caae-91fc-e053-2995a90aef3c.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
75056-00375056-003-01

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
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)T967IEU43CIACT
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
ef199777-e52e-f9e7-e053-2995a90a76eda48404d6-caae-91fc-e053-2995a90aef3c2022-12-05WarningsExact identifier
spl id: ef199777-e52e-f9e7-e053-2995a90a76ed
spl set id: a48404d6-caae-91fc-e053-2995a90aef3c

Reported adverse events (FAERS/openFDA)#

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