Detroderm Soft Gel Hand And Skin Antiseptic
FDA Label NDC 79506-103
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.
Label Section Quick Index
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
* Please review the disclaimer below.