Element Control Rinse-Free Hand Sanitizer Soothing Gel

Manufacturer
Strategic Orient Sourcing Limited
Effective date
2020-08-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:35

Label at a glance#

ProductElement Control Rinse Free Hand Sanitizer Soothing
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • helps reduce bacteria that potentially can cause disease.
  • helps prevent cross contamination by hand contact.
  • recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from heat or flame.

Do not use 

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if irritation and redness develop

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

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

SPL UNCLASSIFIED SECTION

  • avoid freezing and excessive heat above 40°C (104°F)
  • may discolor certain fabrics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Aloe Barbadensis Extract, Aminomethyl Propanol, Propylene Glycol, Carbomer, Fragrance, Tocopherol.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box6Box6

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79995-027-012022-01-28C16284748780-1d6a99b39-9311-a426-e053-dadaa90af4c2Element Control Rinse-Free Hand Sanitizer Soothing Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79995-027-01Element Control Rinse Free Hand Sanitizer Soothing500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79995-027ELEMENT CONTROL RINSE FREE HAND SANITIZER SOOTHING (ALCOHOL) GEL [STRATEGIC ORIENT SOURCING LIMITED]1Legacy NDC, 1 package rows20200813_acafa38c-de1c-327c-e053-2995a90a8842.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79995-02779995-027-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
acafa747-64dd-6440-e053-2995a90a8182acafa38c-de1c-327c-e053-2995a90a88422020-08-12WarningsExact identifier
spl id: acafa747-64dd-6440-e053-2995a90a8182
spl set id: acafa38c-de1c-327c-e053-2995a90a8842

Reported adverse events (FAERS/openFDA)#

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