SaniClean Alcohol Antiseptic 80% Topical Solution Gel, Unscented (HP2463)

Manufacturer
HPPE LLC | HPPE, LLC
Effective date
2020-07-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:20:15

Label at a glance#

ProductSaniClean Alcohol Antiseptic 80% Topical Solution Gel, Unscented (HP2463)
Active ingredientALCOHOL
Label structure12 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.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

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

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, methylcellulose, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000000 mL NDC: 58039-102-01

1000 L Label1000 L Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN2
1041498ethanol 0.8 ML/ML Topical GelSCD2
1041498ethanol 80 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58039-102-01SaniClean Alcohol Antiseptic 80% Topical Solution Gel, Unscented (HP2463)1000000 mL in 1 CONTAINERGEL10000002
58039-102-02SaniClean Alcohol Antiseptic 80% Topical Solution Gel, Unscented (HP2463)59 mL in 1 BOTTLEGEL592
58039-102-03SaniClean Alcohol Antiseptic 80% Topical Solution Gel, Unscented (HP2463)120 mL in 1 BOTTLEGEL1202
58039-102-04SaniClean Alcohol Antiseptic 80% Topical Solution Gel, Unscented (HP2463)250 mL in 1 BOTTLEGEL2502
58039-102-05SaniClean Alcohol Antiseptic 80% Topical Solution Gel, Unscented (HP2463)500 mL in 1 BOTTLEGEL5002
58039-102-06SaniClean Alcohol Antiseptic 80% Topical Solution Gel, Unscented (HP2463)3780 mL in 1 BOTTLEGEL37802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58039-102SANICLEAN ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION GEL, UNSCENTED (HP2463) (ALCOHOL) GEL [HPPE LLC]2Legacy NDC, 6 package rows20200707_a9c68f8c-46aa-e42e-e053-2995a90a2424.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58039-10258039-102-01, 58039-102-02, 58039-102-03, 58039-102-04, 58039-102-05, 58039-102-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
a9c733ac-5ec6-40f6-e053-2a95a90a11e2a9c68f8c-46aa-e42e-e053-2995a90a24242020-07-06WarningsExact identifier
spl id: a9c733ac-5ec6-40f6-e053-2a95a90a11e2
spl set id: a9c68f8c-46aa-e42e-e053-2995a90a2424

Reported adverse events (FAERS/openFDA)#

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