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| Product NDC Code | 79506-103 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Detroderm soft gel hand and skin antiseptic |
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| Type | Brand | ||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||
| Dosage Form | GEL | ||||||||||||||
| RxCUI drug identifier | 1041498 | ||||||||||||||
| Application Number | part333A | ||||||||||||||
| Labeler Name | DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI | ||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient %80 (V/V) Ethanol
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, glycerin, triethanolamine, essence, deionized water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.DETRODERM SOFT geL HAND AND SKIN ANTISEPTIC Alcohol ALCOHOL ALCOHOL CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) GLYCERIN TROLAMINE WATER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Packaging IMAGE
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
• Wide Effect Spectrum • Alcohol Based • Extensive Skin Compatibility • Usable at Dispenser Email: [email protected] 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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions You may also report serious side effects to this phone number (+1-XXX-XXX-XXXX) Mon-Fri 9:00 AM - 5:00 PM
Storage and handling
Information about safe storage and handling of the drug product.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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API