Hand Sanitizer

Manufacturer
Medek, LLC
Effective date
2020-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:10

Label at a glance#

ProductHand Sanitizer
Active ingredientHYPOCHLOROUS ACID
Label structure13 sections

Dosage and administration

Apply a small amount of product into hands and rub between both sides of hands until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store below 83F (30C) Avoid freezing.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

Hypochlorous Acid (0.0005% volume/volume (v/v)).

Triethanolamine (1.2% v/v).

Edetic Acid (0.05% v/v).

Carbopol (1.0% v/v).

Demineralized water.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Hypochlorous Acid 0.0005% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Antiseptic hand sanitizer to reduce germs on skin. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Keep out of reach of children.

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, rash or redness 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, rash or redness 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 product into hands and rub between both sides of hands until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

Store below 83F (30C)

Avoid freezing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

demineralized water, triethanolamine, carbomer and stabilizers

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

250 mL NDC: 75432-002-01

8 oz clorigel8 oz clorigel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75432-002-012022-01-28C16284748780-1d6a99b39-a87e-a426-e053-dadaa90af4c2Hand Sanitizer - Hypochlorous Acid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75432-002-01Hand Sanitizer250 mL in 1 BOTTLEGEL2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75432-002HAND SANITIZER (HYPOCHLOROUS ACID) GEL [MEDEK, LLC]1Legacy NDC, 1 package rows20200605_a73d4919-c7d2-d72f-e053-2995a90a8cac.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
75432-00275432-002-01

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
a73ce7e3-a8a7-5858-e053-2a95a90a0c07a73d4919-c7d2-d72f-e053-2995a90a8cac2020-06-04WarningsExact identifier
spl id: a73ce7e3-a8a7-5858-e053-2a95a90a0c07
spl set id: a73d4919-c7d2-d72f-e053-2995a90a8cac

Reported adverse events (FAERS/openFDA)#

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