Otc - Active Ingredient
Alcohol (45%), Isopropyl Alcohol (30%), Benzalkonium Chloride (0,13%) (w/w)
Creamol Alcohol Wipes
FDA Label NDC 77892-0005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laber Kimya Ar-ge Sanayi Ticaret - Levent Kahriman for the product Creamol Alcohol Wipes (NDC 77892-0005). 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 otc - active ingredient, otc - purpose, directions, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic
Directions
Used for hand and skin cleaning. Open the label and take one. Gently wipe your hands with an antibacterial wipe. It does not require rinsing after use.
Indications & Usage
It provides a practical cleaning without using water and soap when necessary. It helps reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
For external use only. Flammable, keep away from fire and flame.
Otc - Do Not Use
Do not use on open wounds and in children less than 2 months of age
Otc - When Using
Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes throughly with water.
Otc - Stop Use
If irritation and redness develops and persist and in case of poisoning stop use and ask a doctor. Symptoms of Poisoning are dizziness, loss of consciousness and speech disorder.
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.
Inactive Ingredient
Aqua, Glycerine, Parfum, D-Panthenol, Tocopheryl Acetate
Other Informations
Store between 15-30 °C. Avoid freezing and excessive heat above 40°C
* Please review the disclaimer below.
