FDA.reportPublic FDA data

Antiseptique Advance Strength

Manufacturer
Hubot Healthcare LLC
Effective date
2020-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:04:19

Label at a glance#

ProductAntiseptique Advance Strength
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. 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 15-30°C (59-86°F), Avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 80% v/v

Purposes

OTC - PURPOSE SECTION

Antiseptic handwash

Uses

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 eyes | on children less than 2 months old | on open skin wounds

When using this product

OTC - WHEN USING SECTION

  • 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 skin irritation or rash occurs. There may be signs of a serious conditions.

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 15-30°C (59-86°F), Avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water USP, Glycerin, Hydrogen Peroxide

Questions?

OTC - QUESTIONS SECTION

Email: sales@tri-pac.us

PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTISEPTIQUE+
ADVANCED STRENGTH
sanitizer mist

Alcohol Antiseptic 80%
Topical Non-sterile Solution

2 FL. OZ. (59 ML)

PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label
PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1241663ethanol 80 % Topical SprayPSN1
1241663ethanol 0.8 ML/ML Topical SpraySCD1
1241663ethanol 80 % Topical SpraySY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72138-420-162021-07-23C16284748780-1c7ccaba7-2898-fd44-e053-dadaa90aa01bAntiseptique Advance Strength
72138-420-202021-07-23C16284748780-1c7ccaba7-2898-fd44-e053-dadaa90aa01bAntiseptique Advance Strength
72138-420-402021-07-23C16284748780-1c7ccaba7-2898-fd44-e053-dadaa90aa01bAntiseptique Advance Strength
72138-420-602021-07-23C16284748780-1c7ccaba7-2898-fd44-e053-dadaa90aa01bAntiseptique Advance Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72138-420-16Antiseptique Advance Strength472 mL in 1 BOTTLE, PLASTICSPRAY4721
72138-420-20Antiseptique Advance Strength59 mL in 1 BOTTLE, SPRAYSPRAY591
72138-420-40Antiseptique Advance Strength118 mL in 1 BOTTLE, SPRAYSPRAY1181
72138-420-60Antiseptique Advance Strength177 mL in 1 BOTTLE, SPRAYSPRAY1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72138-420ANTISEPTIQUE ADVANCE STRENGTH (ALCOHOL) SPRAY [HUBOT HEALTHCARE LLC]1Legacy NDC, 4 package rows20200331_28569ea5-29dc-4194-a898-cd7d0f44c24e.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72138-42072138-420-20, 72138-420-40, 72138-420-60, 72138-420-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Hydrogen PeroxideBBX060AN9VIACT

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
3cd7a637-6efb-455c-a723-6b731608479028569ea5-29dc-4194-a898-cd7d0f44c24e2020-03-25WarningsExact identifier
spl id: 3cd7a637-6efb-455c-a723-6b7316084790
spl set id: 28569ea5-29dc-4194-a898-cd7d0f44c24e

Reported adverse events (FAERS/openFDA)#

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