FDA.reportPublic FDA data

b4 Antiseptic Hand Sanitizer with ethyl alcohol gel

Manufacturer
Midway Advanced Products, LLC
Effective date
2018-02-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:25

Label at a glance#

Productb4 Antiseptic Hand Sanitizer with ethyl alcohol
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

to sanitize hands without water kills 99% of most common bacteria

Dosage and administration

tear open packet and apply entire amount of gel to unsoiled hands rub in thoroughly until hands are dry do not wipe or use water rinse

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65% w/w

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

  • to sanitize hands without water
  • kills 99% of most common bacteria

Warnings

WARNINGS SECTION

FLAMMABLE. For external use only.

When using this product:

OTC - WHEN USING SECTION

  • keep away from fire or flame
  • do not use in eyes
  • discontinue use if irritation or redness develop

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • tear open packet and apply entire amount of gel to unsoiled hands
  • rub in thoroughly until hands are dry
  • do not wipe or use water rinse

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Aloe Vera Gel, Carbomer, Diisopropylamine, Glycerin, Isopropyl Myristate, Fragrance, Phenoxyethanol, Tocopheryl Acetate, D&C Yellow # 10, FD&C Yellow #5, FD&C Blue #1

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image 200Image 200

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN1
902574ethanol 0.65 ML/ML Topical GelSCD1
902574ethyl alcohol 65 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52490-201-102020-01-31C16284748780-19d75b9cf-e507-f424-e053-dadaa90a57ceb4 Antiseptic Hand Sanitizer with ethyl alcohol gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52490-201-10b4 Antiseptic Hand Sanitizer with ethyl alcohol1.2 mL in 1 CARTONGEL1.21
52490-201-10b4 Antiseptic Hand Sanitizer with ethyl alcohol500 in 1 CARTONGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52490-201B4 ANTISEPTIC HAND SANITIZER WITH ETHYL ALCOHOL (ETHYL ALCOHOL) GEL [MIDWAY ADVANCED PRODUCTS, LLC]1Legacy NDC, 2 package rows20180208_ac7d5bcd-95dd-449d-b26d-4f6abf7caa2b.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52490-20152490-201-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
DIISOPROPYLAMINEBR9JLI40NOIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
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
64a29167-07a0-4d3f-e053-2991aa0a5446ac7d5bcd-95dd-449d-b26d-4f6abf7caa2b2018-02-07WarningsExact identifier
spl id: 64a29167-07a0-4d3f-e053-2991aa0a5446
spl set id: ac7d5bcd-95dd-449d-b26d-4f6abf7caa2b

Reported adverse events (FAERS/openFDA)#

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