Active Ingredient(S)
Benzalkonium chloride (Quaternary ammonium compounds, benzyl (C12-16) alkyldimethyl, chlorides) %0,13 (w/w). Purpose: Antiseptic
Creamol Antibacterial Wet Wipes 100 Pcs
FDA Label NDC 77892-024
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 Antibacterial Wet Wipes 100 Pcs (NDC 77892-024). 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, Hand Sanitizer
Use
Hand Sanitizer Wet Wipes to help 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 heat or flame
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 or 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
Wipe hands; discard
Other Information
· Store between 15-30 °C (59-86 °F)
· Avoid freezing and excessive heat above 40 °C (104 °F)
Inactive Ingredients
Aqua, Glycerin, Phenoxyethanol, Polysorbate 20, Sodium PCA, Tetrasodium EDTA, Ethylhexylglycerin, Citric acid
* Please review the disclaimer below.
