DuraShield Fragrance Free Hand Sanitizer

Manufacturer
CK Polymers LLC
Effective date
2022-04-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:49:17

Label at a glance#

ProductDuraShield Fragrance Free Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

DuraShield® Fragrance Free

SPL UNCLASSIFIED SECTION

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Benzalkonium chloride 0.13% 

Purpose

OTC - PURPOSE SECTION

Purpose: hand sanitizer

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 in children less than 2 months of age or on open skin wounds.

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.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

STORAGE AND HANDLING SECTION

Store between 15-30°C (59-86°F)

Avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, corn starch, soybean oil, petrolatum, pectin, xanthan gum, citricidal, tributyl phosphate, methyl paraben, propyl paraben, vitamin E acetate, white linen fragrance

INACTIVE INGREDIENT SECTION

Questions

275 Gallon Tote - DuraShield® Fragrance Free Hand Sanitizer - Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

nat-275-gallon-tote-2nat-275-gallon-tote-2

55 Gallon Drum - DuraShield® Fragrance Free Hand Sanitizer - Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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330 Gallon Tote - DuraShield® Fragrance Free - Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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2OZ Bottlel - DuraShield® Fragrance Free Hand Sanitizer - Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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4OZ Bottlel - DuraShield® Fragrance Free Hand Sanitizer - Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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8OZ Bottlel - DuraShield® Fragrance Free Hand Sanitizer - Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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5 Gallon Pail - DuraShield® Fragrance Free Hand Sanitizer - Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5-label-25-label-2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78235-012-012023-07-28C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-022023-07-28C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-032023-07-28C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-042023-07-28C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-052023-07-28C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-062023-07-28C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-072023-07-28C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-082023-07-28C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-012022-04-20C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-022022-04-20C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-032022-04-20C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-042022-04-20C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-052022-04-20C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-062022-04-20C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-072022-04-20C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-082022-04-20C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-012022-01-28C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-022022-01-28C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-032022-01-28C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-042022-01-28C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-052022-01-28C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-062022-01-28C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-072022-01-28C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free
78235-012-082022-01-28C16284748780-1d6a99b39-e50a-a426-e053-dadaa90af4c2DuraShield® Fragrance Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78235-012-01DuraShield Fragrance Free Hand Sanitizer3785 mL in 1 JUGLOTION37854
78235-012-02DuraShield Fragrance Free Hand Sanitizer208175 mL in 1 DRUMLOTION2081754
78235-012-03DuraShield Fragrance Free Hand Sanitizer18927.1 mL in 1 CONTAINERLOTION18927.14
78235-012-04DuraShield Fragrance Free Hand Sanitizer1249050 mL in 1 CONTAINERLOTION12490504
78235-012-05DuraShield Fragrance Free Hand Sanitizer1040875 mL in 1 CONTAINERLOTION10408754
78235-012-06DuraShield Fragrance Free Hand Sanitizer60 mL in 1 CONTAINERLOTION604
78235-012-07DuraShield Fragrance Free Hand Sanitizer118 mL in 1 CONTAINERLOTION1184
78235-012-08DuraShield Fragrance Free Hand Sanitizer237 mL in 1 CONTAINERLOTION2374

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78235-012DURASHIELD FRAGRANCE FREE HAND SANITIZER (BENZALKONIUM CHLORIDE LOTION) LOTION [CK POLYMERS LLC]4Legacy NDC, 8 package rows20220421_f2fee473-d3c0-4dfe-94dd-6314f5d49dd0.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
33272bda-35d0-4d8b-b6d5-12f920da4df4f2fee473-d3c0-4dfe-94dd-6314f5d49dd02022-04-20WarningsExact identifier
spl id: 33272bda-35d0-4d8b-b6d5-12f920da4df4
spl set id: f2fee473-d3c0-4dfe-94dd-6314f5d49dd0

Reported adverse events (FAERS/openFDA)#

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