Detroderm Soft Gel Hand And Skin Antiseptic
FDA Label NDC 79506-103

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Detro Healthcare Kimya Sanayi Anonim Sirketi for the product Detroderm Soft Gel Hand And Skin Antiseptic (NDC 79506-103). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredient

%80 (V/V) Ethanol

Purpose

Antiseptic

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.

Warnings

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

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

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

Questions

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

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

Packaging

Image (79506103 1)

Image (79506103 1)

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