FDA.reportPublic FDA data

Mighty Antibacterial Hand Gel Antiseptic Alcohol 70%

Manufacturer
Mighty Distributing System Of America
Effective date
2020-12-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:01:23

Label at a glance#

ProductMighty Antibacterial Hand Antiseptic Alcohol 70
Active ingredientALCOHOL
Label structure10 sections

Dosage and administration

Apply to clean, dry hands. Wet hands thoroughly with product and allow to dry.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

PURPOSE

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

as an instant hand antiseptic. This product DOES NOT replace hand washing with soap and water.

WARNINGS:

WARNINGS SECTION

Flammable, keep away from fire or flame. For external use only. Read label before use.

WHEN USING THIS PRODUCT:

OTC - WHEN USING SECTION

Keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water. Stop use and ask a doctor if significant irritation or sensitization develops.

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Apply to clean, dry hands. Wet hands thoroughly with product and allow to dry.

OTHER INFORMATION:

SPL UNCLASSIFIED SECTION

*Kills 99.99% of E. Coli, Salmonella spp and P. aeruginosa

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Water, carbomer, aminomethyl propanol, glycerin

Package Labeling:60 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:490 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling:930 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

Package Labeling:3.78 L

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

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
81245-00281245-002-01, 81245-002-02, 81245-002-03, 81245-002-04

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
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
GLYCERINPDC6A3C0OXIACT
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
d00d292c-8dfc-4c17-e053-2995a90ae6f3b6afbe38-dabe-34da-e053-2a95a90a88102021-11-05WarningsExact identifier
spl set id: b6afbe38-dabe-34da-e053-2a95a90a8810

Reported adverse events (FAERS/openFDA)#

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