DETRODERM SOFT geL HAND AND SKIN ANTISEPTIC

Manufacturer
DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI
Effective date
2021-04-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:55

Label at a glance#

ProductDETRODERM SOFT geL HAND AND SKIN ANTISEPTIC
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

Hygienic and surgical antiseptic of hands and skin. It is used at all health institutions like surgery, intensive care, clinics, dental clinics, laboratory, veterinary, patient care at home.

Dosage and administration

For hygienic hand antiseptic, at least 3 ml solution is applied to hand without dilution and hands are rubbed until drying. For surgical hand antiseptic, 5 ml solution is applied to hand.

Storage and handling

Store containers tightly closed and in a well-ventilated area between 0-30°C and away from direct sunlight. Do not use after expiry date.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

%80 (V/V) Ethanol

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hygienic and surgical antiseptic of hands and skin. It is used at all health institutions like surgery, intensive care, clinics, dental clinics, laboratory, veterinary, patient care at home.

Warnings

WARNINGS SECTION

Flammable. Keep out of ignition sources directly.

Do not use

Before reading user manual

After 6 months from cover opening

When using this product

No smoking. must not be contacted with powerful oxidants, alkali metals due to fire and explosion possibility. Keep out of reach of children, food and animal foods. Keep out of ignition sources directly. Do not stock with oxidant and spontaneously combustible materials. Obey instructions existed in user manual.

Stop use and ask a doctor if

*In case of poisoning

*In case of ingestion

*In case of contact with eyes

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

For hygienic hand antiseptic, at least 3 ml solution is applied to hand without dilution and hands are rubbed until drying. For surgical hand antiseptic, 5 ml solution is applied to hand.

Other Information

STORAGE AND HANDLING SECTION

Store containers tightly closed and in a well-ventilated area between 0-30°C and away from direct sunlight.

Do not use after expiry date.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, glycerin, triethanolamine, essence, deionized water

Questions

OTC - QUESTIONS SECTION

You may also report serious side effects to this phone number (+1-XXX-XXX-XXXX)

Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

• Wide Effect Spectrum

• Alcohol Based

• Extensive Skin Compatibility

• Usable at Dispenser

Email: international@detrox.com.tr

MADE IN TURKEY

detrox®

Integrated Disinfection Solutions

Producer Name and Address:

Detro Healthcare Kimya Sanayi A.S.

Ataturk mh. Adnan Menderec cd.

No:7 Esenyurt/Istanbul-Turkey

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN1
1041498ethanol 0.8 ML/ML Topical GelSCD1
1041498ethanol 80 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79506-103-01DETRODERM SOFT geL HAND AND SKIN ANTISEPTIC5000 mL in 1 CONTAINERGEL50001
79506-103-02DETRODERM SOFT geL HAND AND SKIN ANTISEPTIC3780 mL in 1 BOTTLEGEL37801
79506-103-03DETRODERM SOFT geL HAND AND SKIN ANTISEPTIC1000 mL in 1 BOTTLEGEL10001
79506-103-04DETRODERM SOFT geL HAND AND SKIN ANTISEPTIC500 mL in 1 BOTTLEGEL5001
79506-103-05DETRODERM SOFT geL HAND AND SKIN ANTISEPTIC250 mL in 1 BOTTLEGEL2501
79506-103-06DETRODERM SOFT geL HAND AND SKIN ANTISEPTIC100 mL in 1 BOTTLEGEL1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79506-103DETRODERM SOFT GEL HAND AND SKIN ANTISEPTIC (ALCOHOL) GEL [DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI]1Legacy NDC, 6 package rows20210424_c7cda759-43cb-4b82-b7cc-f97753ceeaa1.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
79506-10379506-103-01, 79506-103-02, 79506-103-03, 79506-103-04, 79506-103-05, 79506-103-06

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
a92d86fa-7667-4406-8145-d37782bbbe26c7cda759-43cb-4b82-b7cc-f97753ceeaa12021-04-20WarningsExact identifier
spl id: a92d86fa-7667-4406-8145-d37782bbbe26
spl set id: c7cda759-43cb-4b82-b7cc-f97753ceeaa1

Reported adverse events (FAERS/openFDA)#

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