FDA.reportPublic FDA data

X PROUSA Antiseptic Hand Sanitizer Gel

Manufacturer
X-PROUSA LLC
Effective date
2020-08-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:25:53

Label at a glance#

ProductX PROUSA Antiseptic Hand Sanitizer Gel
Active ingredientALCOHOL
Label structure13 sections

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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 72%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • Hand sanitizer to help reduce bacteria on the skin that could cause disease
  • Recommended for repeated use

Warnings

WARNINGS SECTION

  • For external use only
  • Flammable, keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • Do not use on children less than 2 months of age
  • Do not use 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.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Acrylates/C10-30 Alkyl Crylate Crosspolymer, Aminomethyl propanol, Vitamin E Acetate

 79490-000-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box.Box.

79490-000-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box2.Box2.

79490-000-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box3.Box3.

79490-000-08

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box4.Box4.

79490-000-16

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box5.Box5.

79490-000-32

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box6.Box6.

79490-000-38

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box7.Box7.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2277550ethanol 72 % Topical GelPSN2
2277550ethanol 0.72 ML/ML Topical GelSCD2
2277550ethanol 72 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79490-000-012022-01-28C16284748780-1d6a99b39-fb0f-a426-e053-dadaa90af4c2X-PROUSA Antiseptic Hand Sanitizer Gel
79490-000-022022-01-28C16284748780-1d6a99b39-fb0f-a426-e053-dadaa90af4c2X-PROUSA Antiseptic Hand Sanitizer Gel
79490-000-042022-01-28C16284748780-1d6a99b39-fb0f-a426-e053-dadaa90af4c2X-PROUSA Antiseptic Hand Sanitizer Gel
79490-000-082022-01-28C16284748780-1d6a99b39-fb0f-a426-e053-dadaa90af4c2X-PROUSA Antiseptic Hand Sanitizer Gel
79490-000-162022-01-28C16284748780-1d6a99b39-fb0f-a426-e053-dadaa90af4c2X-PROUSA Antiseptic Hand Sanitizer Gel
79490-000-322022-01-28C16284748780-1d6a99b39-fb0f-a426-e053-dadaa90af4c2X-PROUSA Antiseptic Hand Sanitizer Gel
79490-000-382022-01-28C16284748780-1d6a99b39-fb0f-a426-e053-dadaa90af4c2X-PROUSA Antiseptic Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79490-000-01X PROUSA Antiseptic Hand Sanitizer Gel30 mL in 1 BOTTLEGEL302
79490-000-02X PROUSA Antiseptic Hand Sanitizer Gel60 mL in 1 BOTTLEGEL602
79490-000-04X PROUSA Antiseptic Hand Sanitizer Gel118 mL in 1 BOTTLEGEL1182
79490-000-08X PROUSA Antiseptic Hand Sanitizer Gel240 mL in 1 BOTTLEGEL2402
79490-000-16X PROUSA Antiseptic Hand Sanitizer Gel470 mL in 1 BOTTLEGEL4702
79490-000-32X PROUSA Antiseptic Hand Sanitizer Gel950 mL in 1 BOTTLEGEL9502
79490-000-38X PROUSA Antiseptic Hand Sanitizer Gel3800 mL in 1 BOTTLEGEL38002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79490-000X PROUSA ANTISEPTIC HAND SANITIZER GEL (ALCOHOL) GEL [X-PROUSA LLC]2Legacy NDC, 7 package rows20200827_ab6cfcf8-19eb-a2e9-e053-2a95a90a5828.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79490-00079490-000-01, 79490-000-02, 79490-000-04, 79490-000-08, 79490-000-16, 79490-000-32, 79490-000-38

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
adcd85dc-829d-1e57-e053-2995a90ac799ab6cfcf8-19eb-a2e9-e053-2a95a90a58282020-08-26WarningsExact identifier
spl id: adcd85dc-829d-1e57-e053-2995a90ac799
spl set id: ab6cfcf8-19eb-a2e9-e053-2a95a90a5828

Reported adverse events (FAERS/openFDA)#

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