Active Ingredient(S)
Ethyl alcohol 70% w/w, 2-Propanol 0.5% w/w
I D Anti Bacterial Alcohol Based Hand And Skin Disinfectant
FDA Label NDC 78992-608
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dth Saglik Hizmetleri Ticaret Anonim Sirketi for the product I D Anti Bacterial Alcohol Based Hand And Skin Disinfectant (NDC 78992-608). 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 active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Alcohol-based hand disinfectant
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease. Effective against bacteria, fungi, viruses. For use when soap and water are not available.
Warnings
This product is only for external use. Keep away from children, food, and animal feed. Do not swallow.
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation and rash occurs. These may be signs of a serious condition.
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
Put enough product ( app.3-5 ml) on hands to cover all surfaces. Rub hands together, until hands feel dry. This should take around 20 seconds. Do not rinse or wipe off the hand sanitizer before it's dry; it may not work as well against germs.
Supervise children under 6 years of age when they use hand sanitizer gel to prevent swallowing alcohol, especially in schools and childcare facilities.
Other Information
Do not use other disinfectant and cleaning agents. It should be used in its orginal packaging. Store between 15-30 C ( 59-86F).Protect from direct sunlight. Avoid freezing and excessive heat above 40C(104F)
Inactive Ingredients
Glycerin, Fragrance, Citric acid, Purified water USP
Package Label - Principal Display Panel
DTH Saglik Hizmetleri Tic. A.S. Merkez: Incek Mehmetcik Cad. 2654. Sk. No:2 Golbasi-Ankara
T: +90 312 211 05 06 F: +90 312 211 05 00
wwww.dthsaglik.com - www.idkimya.com
I& D sept INTERNATIONAL DISINFECTION
ANTI-BACTERIAL ALCOHOL BASED HAND AND SKIN SPRAY DISINFECTANT
For External Use Only
KILLS 99,9% of germs without water
KILLS 99,9% VIRUSES & BACTERIA
* Please review the disclaimer below.
