FDA.reportPublic FDA data

Gel Hand Sanitizer

Manufacturer
5 Peaks Products, LLC
Effective date
2020-09-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:11

Label at a glance#

ProductGel Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Put enough hand sanitizer on your palm to cover hands & rub hands together until dry. Children under 5 should be supervised using this product.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

To help reduce bacteria on skin.

Warnings

WARNINGS SECTION

For external use only. Flammable, keep away from source of heat & fire.

OTC - WHEN USING SECTION

When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use & ask doctor if irritation occurs or redness develops & persists.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, seek medical help and contact a Poison Control Center Immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Put enough hand sanitizer on your palm to cover hands & rub hands together until dry. Children under 5 should be supervised using this product.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua, Eau), Glycerin, Liquid Preneutralized Thickener/Emulsifier, Squalane, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Tocopheryl Acetate.

RECENT MAJOR CHANGES SECTION

Section 3:
To help reduce bacteria on skin. (09/2020)

Section 8:
Put enough hand sanitizer on your palm to cover hands & rub hands together until dry. Children under 5 should be supervised using this product. (09/2020)

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5 Peaks 3.4oz Tube5 Peaks 3.4oz Tube5 Peaks 8.45 oz Bottle5 Peaks 8.45 oz Bottle5 Peaks 16.9 oz Bottle5 Peaks 16.9 oz Bottle5 Peaks 1 Liter Bottle5 Peaks 1 Liter Bottle5 Peaks 1 Gallon Bottle5 Peaks 1 Gallon Bottle5 Peaks 55 Gallon Drum5 Peaks 55 Gallon Drum5 Peaks 1000 L IBC Tote5 Peaks 1000 L IBC Tote

100 mL NDC: 80242-100-01

250 mL NDC: 80242-100-02

500 mL NDC: 80242-100-03

1 L NDC: 80242-100-04

3.785 L NDC: 80242-100-05

208 L NDC: 80242-100-06

1000 L NDC: 80242-100-07

iUnderstand Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

iUnderstand 8.45 oz bottleiUnderstand 8.45 oz bottleiUnderstand 16.9 oz bottleiUnderstand 16.9 oz bottleiUnderstand 1 Liter BottleiUnderstand 1 Liter Bottle

250 mL NDC: 80242-100-02

500 mL NDC: 80242-100-03

1 L NDC: 80242-100-04

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
80242-100-012022-01-28C16284748780-1d6a99b39-b00f-a426-e053-dadaa90af4c270% Gel Hand Sanitizer
80242-100-022022-01-28C16284748780-1d6a99b39-b00f-a426-e053-dadaa90af4c270% Gel Hand Sanitizer
80242-100-032022-01-28C16284748780-1d6a99b39-b00f-a426-e053-dadaa90af4c270% Gel Hand Sanitizer
80242-100-042022-01-28C16284748780-1d6a99b39-b00f-a426-e053-dadaa90af4c270% Gel Hand Sanitizer
80242-100-052022-01-28C16284748780-1d6a99b39-b00f-a426-e053-dadaa90af4c270% Gel Hand Sanitizer
80242-100-062022-01-28C16284748780-1d6a99b39-b00f-a426-e053-dadaa90af4c270% Gel Hand Sanitizer
80242-100-072022-01-28C16284748780-1d6a99b39-b00f-a426-e053-dadaa90af4c270% Gel Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80242-100-01Gel Hand Sanitizer100 mL in 1 TUBEGEL1001
80242-100-02Gel Hand Sanitizer250 mL in 1 BOTTLEGEL2501
80242-100-03Gel Hand Sanitizer500 mL in 1 BOTTLEGEL5001
80242-100-04Gel Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
80242-100-05Gel Hand Sanitizer3785 mL in 1 BOTTLEGEL37851
80242-100-06Gel Hand Sanitizer208000 mL in 1 DRUMGEL2080001
80242-100-07Gel Hand Sanitizer1000000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL10000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80242-100GEL HAND SANITIZER (ALCOHOL) GEL [5 PEAKS PRODUCTS, LLC]1Legacy NDC, 7 package rows20200913_af2530a9-92a2-0b43-e053-2995a90ae8c5.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80242-10080242-100-01, 80242-100-02, 80242-100-03, 80242-100-04, 80242-100-05, 80242-100-06, 80242-100-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
SQUALANEGW89575KF9IACT
RAPIDGEL EZ133JH4A7R2KIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
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
af252c98-af6a-2be5-e053-2995a90a76dbaf2530a9-92a2-0b43-e053-2995a90ae8c52020-09-12WarningsExact identifier
spl id: af252c98-af6a-2be5-e053-2995a90a76db
spl set id: af2530a9-92a2-0b43-e053-2995a90ae8c5

Reported adverse events (FAERS/openFDA)#

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