FDA.reportPublic FDA data

Antiseptique 70

Manufacturer
Hubot Healthcare LLC
Effective date
2020-06-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:33

Label at a glance#

ProductAntiseptique 70
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

to help reduce bacteria on skin

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 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F) | For additional information, see Safety Data Sheets (SDS)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purposes

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

to help reduce bacteria on 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 years 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

|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 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F) | For additional information, see Safety Data Sheets (SDS)

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

sales@tri-pac.us

PRINCIPAL DISPLAY PANEL - 946 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTISEPTIQUE+70
gel sanitizer

antiseptic | rinse-free | 70% alcohol

FOR HANDS
dye free, fragrance free

FOR HEALTHCARE PROFESSIONALS ONLY

32 FL. OZ. (946 ML)

PRINCIPAL DISPLAY PANEL - 946 ML Bottle Label
PRINCIPAL DISPLAY PANEL - 946 ML Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72138-460-062021-07-23C16284748780-1c7ccaba7-2a2d-fd44-e053-dadaa90aa01bAntiseptique + 70
72138-460-082021-07-23C16284748780-1c7ccaba7-2a2d-fd44-e053-dadaa90aa01bAntiseptique + 70
72138-460-162021-07-23C16284748780-1c7ccaba7-2a2d-fd44-e053-dadaa90aa01bAntiseptique + 70
72138-460-322021-07-23C16284748780-1c7ccaba7-2a2d-fd44-e053-dadaa90aa01bAntiseptique + 70

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72138-460-06Antiseptique 70177 mL in 1 BOTTLE, PLASTICGEL1771
72138-460-08Antiseptique 70236 mL in 1 BOTTLE, PLASTICGEL2361
72138-460-16Antiseptique 70473 mL in 1 BOTTLE, PUMPGEL4731
72138-460-32Antiseptique 70946 mL in 1 BOTTLE, PUMPGEL9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72138-460ANTISEPTIQUE 70 (ALCOHOL) GEL [HUBOT HEALTHCARE LLC]1Legacy NDC, 4 package rows20200630_e94b59b1-7f18-4688-a4e3-4cc338af4f45.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
72138-46072138-460-06, 72138-460-08, 72138-460-16, 72138-460-32

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-8 ISOSTEARATEJGV7463UFNIACT
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
d715d706-add6-471f-bbfa-42db129affd5e94b59b1-7f18-4688-a4e3-4cc338af4f452020-06-29WarningsExact identifier
spl id: d715d706-add6-471f-bbfa-42db129affd5
spl set id: e94b59b1-7f18-4688-a4e3-4cc338af4f45

Reported adverse events (FAERS/openFDA)#

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