FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Kepter Mexico S.A de C.V
Effective date
2020-05-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:29

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:

  1. Hypochlorous Acid (0.0005% volume/volume (v/v)).
  2. Triethanolamine (1.2% v/v).
  3. Edetic Acid (0.05% v/v).
  4. Carbopol (1.0% v/v).
  5. 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 the skin. For use when soap and water 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 doctor: If irritation, rash or redness occurs. These may be signs of 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 doctor: If irritation, rash or redness occurs. These may be signs of 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: 78391-002-01

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
78391-002-012021-07-23C16284748780-1c7ccaba7-25fe-fd44-e053-dadaa90aa01bHand Sanitizer - Hypochlorous Acid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78391-002-01Hand Sanitizer250 mL in 1 BOTTLEGEL2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78391-002HAND SANITIZER (HYPOCHLOROUS ACID) GEL [KEPTER MEXICO S.A DE C.V]1Legacy NDC, 1 package rows20200601_a6ea3096-b140-5494-e053-2a95a90a5042.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
78391-00278391-002-01

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
EDETIC ACID9G34HU7RV0IACT
TROLAMINE9O3K93S3TKIACT
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
HYPOCHLOROUS ACID712K4CDC10ACTIB

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
a6e97b55-256c-0e3b-e053-2a95a90aae30a6ea3096-b140-5494-e053-2a95a90a50422020-05-30WarningsExact identifier
spl id: a6e97b55-256c-0e3b-e053-2a95a90aae30
spl set id: a6ea3096-b140-5494-e053-2a95a90a5042

Reported adverse events (FAERS/openFDA)#

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