SaniClean Plus Alcohol Antiseptic 70% Topical Solution Gel, Lemon Scented (HP2491)

Manufacturer
HPPE, LLC | HPPE LLC
Effective date
2020-07-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:22:01

Label at a glance#

ProductSaniClean Plus Alcohol Antiseptic 70% Topical Solution Gel, Lemon Scented (HP2491)
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 70% 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, hypromellose, lemon fragrance, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000000 mL NDC: 58039-308-01

1000-L Label1000-L Label

236 mL NDC: 58039-308-04

236 mL Label236 mL Label

473 mL NDC: 58039-308-05

473 mL Label473 mL Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58039-308-01SaniClean Plus Alcohol Antiseptic 70% Topical Solution Gel, Lemon Scented (HP2491)1000000 mL in 1 CONTAINERGEL10000003
58039-308-02SaniClean Plus Alcohol Antiseptic 70% Topical Solution Gel, Lemon Scented (HP2491)59 mL in 1 BOTTLEGEL593
58039-308-03SaniClean Plus Alcohol Antiseptic 70% Topical Solution Gel, Lemon Scented (HP2491)118 mL in 1 BOTTLEGEL1183
58039-308-04SaniClean Plus Alcohol Antiseptic 70% Topical Solution Gel, Lemon Scented (HP2491)236 mL in 1 BOTTLEGEL2363
58039-308-05SaniClean Plus Alcohol Antiseptic 70% Topical Solution Gel, Lemon Scented (HP2491)473 mL in 1 BOTTLEGEL4733
58039-308-06SaniClean Plus Alcohol Antiseptic 70% Topical Solution Gel, Lemon Scented (HP2491)3780 mL in 1 BOTTLEGEL37803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58039-308SANICLEAN PLUS ALCOHOL ANTISEPTIC 70% TOPICAL SOLUTION GEL, LEMON SCENTED (HP2491) (ALCOHOL) GEL [HPPE, LLC]3Legacy NDC, 6 package rows20200721_a9ca4703-ef9e-e4e2-e053-2a95a90a82cb.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
58039-30858039-308-01, 58039-308-02, 58039-308-03, 58039-308-04, 58039-308-05, 58039-308-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
aae5226e-d9b2-2f8a-e053-2995a90ade32a9ca4703-ef9e-e4e2-e053-2a95a90a82cb2020-07-20WarningsExact identifier
spl id: aae5226e-d9b2-2f8a-e053-2995a90ade32
spl set id: a9ca4703-ef9e-e4e2-e053-2a95a90a82cb