FDA.reportPublic FDA data

Gel Hand Sanitizer

Manufacturer
BuckAirways Inc. | Berdor Health
Effective date
2020-05-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:13:34

Label at a glance#

ProductGel Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

To decrease bacteria on the skin that could cause disease. Reccomended for repeated use. For use when soap and water are not available.

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

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic; Hand Sanitizer

Uses

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin that could cause disease. Reccomended for repeated use. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only: Hands. Flammable, keep aware from fire or flame.

Do not use

OTC - DO NOT USE SECTION

In children less than 2 months of age. On open skin or 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 ir 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

Purified Water USP, Glycerin, Tocopheryl Acetate (Vitamin E), Panthenol (Vitamin B-6), Polyacrylate Crosspolymer-6, Fragerence

Packaging Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59 ML NDC Code 75396-315-17

FRONT

Front 2 ozFront 2 oz

BACK

Back 2 ozBack 2 oz

118ML NDC Code 75396-315-18

FRONT

Front 4 ozFront 4 oz

BACK

Back 4 ozBack 4 oz

3785ML NDC Code 75396-315-19

FRONT

Front 128 ozFront 128 oz

BACK

Back 128 ozBack 128 oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75396-315-172022-01-28C16284748780-1d6a99b39-582e-a426-e053-dadaa90af4c2a4eec32a-2d99-34f4-e053-2995a90a3d3c
75396-315-182022-01-28C16284748780-1d6a99b39-582e-a426-e053-dadaa90af4c2a4eec32a-2d99-34f4-e053-2995a90a3d3c
75396-315-192022-01-28C16284748780-1d6a99b39-582e-a426-e053-dadaa90af4c2a4eec32a-2d99-34f4-e053-2995a90a3d3c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75396-315-17Gel Hand Sanitizer118 mL in 1 BOTTLE, DISPENSINGGEL1181
75396-315-18Gel Hand Sanitizer59 mL in 1 BOTTLE, DISPENSINGGEL591
75396-315-19Gel Hand Sanitizer3785 mL in 1 JUGGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75396-315GEL HAND SANITIZER (MOISTURIZING GEL HAND SANITIZER) GEL [BUCKAIRWAYS INC.]1Legacy NDC, 3 package rows20200519_a4eec32a-2d99-34f4-e053-2995a90a3d3c.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75396-31575396-315-17, 75396-315-18, 75396-315-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
DEXPANTHENOL1O6C93RI7ZIACT

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
a4eec32a-2d9a-34f4-e053-2995a90a3d3ca4eec32a-2d99-34f4-e053-2995a90a3d3c2020-05-05WarningsExact identifier
spl id: a4eec32a-2d9a-34f4-e053-2995a90a3d3c
spl set id: a4eec32a-2d99-34f4-e053-2995a90a3d3c

Reported adverse events (FAERS/openFDA)#

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