FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Northmed
Effective date
2021-03-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:09

Label at a glance#

ProductHand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

Apply a small amount of gel to the hands and massage. Wait for it to dry. The exposure time is 15-30 seconds. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 41-80F (5-27C). Avoid freezing and excessive heat above 104F (40C).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride, .2%. 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.

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

Apply a small amount of gel to the hands and massage. Wait for it to dry. The exposure time is 15-30 seconds. Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 41-80F (5-27C).
  • Avoid freezing and excessive heat above 104F (40C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water. glycerin, panthenol, aloe vera, hydroxyethyl cellulose, tetrasodium glutamate diacetate, fragrance, chamomile extract, birch leaf extract, elderberry extract

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kids 4L labelKids 4L label4L NDC: 78522-101-01

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7a33b18d-631c-4c4b-93de-9cf1faef5f73Product name120250103

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78522-103-002023-01-30C16284748780-1f386c649-c906-0266-e053-dadaa90a7c1abe507751-ba1b-4ff2-e053-2995a90a7176

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78522-103-00Hand Sanitizer4 L in 1 BOTTLEGEL41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78522-103HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [NORTHMED]1Legacy NDC, 1 package rows20210325_be507751-ba1b-4ff2-e053-2995a90a7176.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78522-10378522-103-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
FRAGRANCE FLORAL ORC0902236R66Z4YW3X0IACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
CHAMOMILE FLOWER OIL60F80Z61A9IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
PANTHENOLWV9CM0O67ZIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
ALOE VERA LEAFZY81Z83H0XIACT
BIRCH TRITERPENESBX09B0RQR0IACT

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
be4ff9f3-9efa-36ca-e053-2a95a90ab0efbe507751-ba1b-4ff2-e053-2995a90a71762021-03-24WarningsExact identifier
spl id: be4ff9f3-9efa-36ca-e053-2a95a90ab0ef
spl set id: be507751-ba1b-4ff2-e053-2995a90a7176

Reported adverse events (FAERS/openFDA)#

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