Dermokil

Manufacturer
Halshe, LLC | EZEL KOZMETIK ITH. VE IHR. TIC. VE SAN. A.Ş.
Effective date
2020-04-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:08:21

Label at a glance#

ProductDermokil
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

- wet hands thoroughly with product - allow to dry without wiping

Storage and handling

Other information - keep out of direct sunlight - store in dry conditions

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 71.5% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

Do not use on damaged, inflamed or broken skin

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes

In case of eye contact, rinse eyes thoroughly with water

Stop use

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops and lasts for more than 72 hours.

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

- wet hands thoroughly with product

- allow to dry without wiping

Other information

STORAGE AND HANDLING SECTION

Other information

- keep out of direct sunlight

- store in dry conditions

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, isopropyl alcohol, sodium hydroxide, purified water USP

Use

INDICATIONS & USAGE SECTION

Use for hand sanitizing to decrease bacteria on the skin

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 ml NDC: 75004-786-55 PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2360897ethanol 71.5 % Topical GelPSN1
2360897ethanol 0.715 ML/ML Topical GelSCD1
2360897ethanol 71.5 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75004-786-552021-07-23C16284748780-1c7ccaba7-1ad6-fd44-e053-dadaa90aa01ba44cec41-bb90-811f-e053-2a95a90a1885

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75004-786-55Dermokil500 mL in 1 BOTTLE, PUMPGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75004-786DERMOKIL (HAND SANITIZER GEL) GEL [HALSHE, LLC]1Legacy NDC, 1 package rows20200428_a44cec41-bb90-811f-e053-2a95a90a1885.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75004-78675004-786-55

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
a44ce0d1-d56e-4a9f-e053-2a95a90a19b3a44cec41-bb90-811f-e053-2a95a90a18852020-04-02WarningsExact identifier
spl id: a44ce0d1-d56e-4a9f-e053-2a95a90a19b3
spl set id: a44cec41-bb90-811f-e053-2a95a90a1885

Reported adverse events (FAERS/openFDA)#

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