FDA.reportPublic FDA data

Antiseptique Sanitizer Mist

Manufacturer
Hubot Healthcare LLC
Effective date
2020-06-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:18:59

Label at a glance#

ProductAntiseptique Sanitizer Mist
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 | Supervise children under 6 years of age when using this product to avoid swallowing.

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| Store between 15-30C (59-86F) | Avoid freexing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65% v/v

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 | on children less than 2 months of age | on open skin wounds

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 | Supervise children under 6 years of age when using this product to avoid swallowing.

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| Store between 15-30C (59-86F) | Avoid freexing and excessive heat above 40C (104F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water (aqua), glycerin,, safflower oil, hydrogenated castor oil, almond oil, coconut oil, jojoba oil, lavender oil

Questions?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTISEPTIQUE+
sanitizer mist

antiseptic | rinse-free | 65% alcohol

FOR HANDS
dye free, fragrance free

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
902515ethanol 65 % Topical SprayPSN3
902515ethanol 0.65 ML/ML Topical SpraySCD3
902515ethanol 65 % Topical SpraySY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72138-400-202021-07-23C16284748780-1c7ccaba7-1af1-fd44-e053-dadaa90aa01bAntiseptique Sanitizer Mist
72138-400-402021-07-23C16284748780-1c7ccaba7-1af1-fd44-e053-dadaa90aa01bAntiseptique Sanitizer Mist
72138-400-602021-07-23C16284748780-1c7ccaba7-1af1-fd44-e053-dadaa90aa01bAntiseptique Sanitizer Mist
72138-400-802021-07-23C16284748780-1c7ccaba7-1af1-fd44-e053-dadaa90aa01bAntiseptique Sanitizer Mist

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72138-400-20Antiseptique Sanitizer Mist59 mL in 1 BOTTLE, SPRAYSPRAY593
72138-400-40Antiseptique Sanitizer Mist118 mL in 1 BOTTLE, SPRAYSPRAY1183
72138-400-60Antiseptique Sanitizer Mist174 mL in 1 BOTTLE, SPRAYSPRAY1743
72138-400-80Antiseptique Sanitizer Mist236 mL in 1 BOTTLE, SPRAYSPRAY2363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72138-400ANTISEPTIQUE SANITIZER MIST (ALCOHOL) SPRAY [HUBOT HEALTHCARE LLC]3Legacy NDC, 4 package rows20200625_be0e3089-9b46-4420-9754-1f0ae56cfae7.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72138-40072138-400-20, 72138-400-40, 72138-400-80, 72138-400-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Safflower Oil65UEH262ISIACT
Almond Oil66YXD4DKO9IACT
Coconut OilQ9L0O73W7LIACT
Jojoba Oil724GKU717MIACT
Spike Lavender Oil7S2HYV1VJQIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT

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
83b8e872-8679-45eb-a23b-1e1bec0638f5be0e3089-9b46-4420-9754-1f0ae56cfae72020-06-17WarningsExact identifier
spl id: 83b8e872-8679-45eb-a23b-1e1bec0638f5
spl set id: be0e3089-9b46-4420-9754-1f0ae56cfae7

Reported adverse events (FAERS/openFDA)#

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