FDA.reportPublic FDA data

Antiseptique

Manufacturer
Hubot Healthcare LLC
Effective date
2020-03-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:04:13

Label at a glance#

ProductAntiseptique
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

for handwashing to decrease bacteria on the skin

Dosage and administration

Apply product onto hands, spread thoroughly and rub dry

Storage and handling

For additional information, see Safety Data Sheets (SDS) For emergency medical information in USA and Canada, call 1-888-255-3924 For emergency medical information worldwide, call 1-813-248-0573

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62.5% w/w

Purposes

OTC - PURPOSE SECTION

Antiseptic handwash

Uses

INDICATIONS & USAGE SECTION

for handwashing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

  • For external use only
  • Flammable, keep away from fire or flame, heat, sparks, and sources of static discharge

Do not use

OTC - DO NOT USE SECTION

  • In eyes

When using this product

OTC - WHEN USING SECTION

  • If in eyes, rinse promptly and thoroughly with water
  • Discontinue use if irritation and redness develops

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation or redness occurs or persists for more than 72 hours.

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

  • Apply product onto hands, spread thoroughly and rub dry

Other Information

STORAGE AND HANDLING SECTION

  • For additional information, see Safety Data Sheets (SDS)
  • For emergency medical information in USA and Canada, call 1-888-255-3924
  • For emergency medical information worldwide, call 1-813-248-0573

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water (aqua), propylene glycol, dimethicone PEG-7 Isostearate, acrylates/ C10-30 Alkyl Acrylate Crosspolymer, aminomethylpropanediol, tocopherol acetate, aloe barbadensis leaf juice

Questions?

OTC - QUESTIONS SECTION

Call 1-855-CLEAN-55 (253-2655)

PRINCIPAL DISPLAY PANEL - 473 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTISEPTIQUE+
gel sanitizer

antiseptic | rinse-free | 62.5% alcohol

FOR HANDS
dye free, fragrance free

16 FL. OZ. (473 ML)

PRINCIPAL DISPLAY PANEL - 473 ML Bottle Label
PRINCIPAL DISPLAY PANEL - 473 ML Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1860080ethanol 62.5 % Topical GelPSN1
1860080ethanol 0.625 ML/ML Topical GelSCD1
1860080ethanol 62.5 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72138-480-062021-07-23C16284748780-1c7ccaba7-24b1-fd44-e053-dadaa90aa01bAntiseptique
72138-480-162021-07-23C16284748780-1c7ccaba7-24b1-fd44-e053-dadaa90aa01bAntiseptique
72138-480-322021-07-23C16284748780-1c7ccaba7-24b1-fd44-e053-dadaa90aa01bAntiseptique

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72138-480-06Antiseptique177 mL in 1 BOTTLE, PUMPGEL1771
72138-480-16Antiseptique473 mL in 1 BOTTLE, PUMPGEL4731
72138-480-32Antiseptique946 mL in 1 BOTTLE, PUMPGEL9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72138-480ANTISEPTIQUE (ALCOHOL) GEL [HUBOT HEALTHCARE LLC]1Legacy NDC, 3 package rows20200327_c416d391-31cb-46b0-ae68-f777662df2b3.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72138-48072138-480-06, 72138-480-16, 72138-480-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
Water059QF0KO0RIACT
Propylene Glycol6DC9Q167V3IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
Dimethicone PEG-7 IsostearateJVS3399FNWIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
TocopherolR0ZB2556P8IACT
Aloe Vera LeafZY81Z83H0XIACT

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
0a6f72c9-618f-449d-b7af-409caf9e27f5c416d391-31cb-46b0-ae68-f777662df2b32020-03-18WarningsExact identifier
spl id: 0a6f72c9-618f-449d-b7af-409caf9e27f5
spl set id: c416d391-31cb-46b0-ae68-f777662df2b3

Reported adverse events (FAERS/openFDA)#

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