FDA.reportPublic FDA data

Moisturizing Hand Sanitizer

Manufacturer
Tumi, Inc | Uniters SpA
Effective date
2020-10-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:13:35

Label at a glance#

ProductMoisturizing Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Dosage and administration

Wet hands thoroughly with product Rub hand together until dry Does not require rinsing

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

Benzalkonium Chloride 0.1% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

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.

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 develops and continues for more than 72 hours.

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 develops and continues 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

Wet hands thoroughly with product

Rub hand together until dry

Does not require rinsing

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

purified water USP, polyquaternium 37 and propylene glycol dicaprylate/dicaprate and ppg-1 trideceth-6, fragrance.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 mL NDC: 80196-088-08

Tumi 50mL bottle labelTumi 50mL bottle label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80196-088-082022-08-11C16284748780-1e4f33bdf-9df4-d8a0-e053-dadaa90a6e4eMoisturizing Hand Sanitizer - Tumi Listing
80196-088-082022-07-29C16284748780-1e4f33bdf-9df4-d8a0-e053-dadaa90a6e4eMoisturizing Hand Sanitizer - Tumi Listing

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
80196-08880196-088-08

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATEO4446S9CRAIACT
PPG-1 TRIDECETH-61K7417JX6QIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
POLYQUATERNIUM-37 (25000 MPA.S)31L31U8285IACT

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
e5fca424-1f60-f61f-e053-2995a90a12e6b0a25e7d-5a16-4dfb-e053-2a95a90a669b2022-08-11WarningsExact identifier
spl set id: b0a25e7d-5a16-4dfb-e053-2a95a90a669b

Reported adverse events (FAERS/openFDA)#

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