Other
Antibacterial Hand Wipes for Personal Use
Loles
FDA Label NDC 73485-003
13 label sections · Submitted to the FDA by Diora Kimya Sanayi Ve Ticaret Limited Sirketi · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Diora Kimya Sanayi Ve Ticaret Limited Sirketi for the product Loles (NDC 73485-003). 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 other, active ingredient(s), purpose, use, warnings, 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
Active Ingredient(S)
Benzalkonium Chloride 0.115%
Purpose: Antibacterial
Purpose
Antibacterial, Hand Wipes
Use
For hand washing to decrease bacteria on the skin.
Warnings
For external use only.
Do Not Use
- In the eyes
- if you are allergic to any of the ingredients.
Otc - When Using
When using this product if eye contact occurs, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor If irritation and redness develop and persist more than 72 hours.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Storage. Store at room temperature.
Dispensing. Lift lid and open seal band. Pull up center sheet and pull through the lid. Close lid to retain moisture.
Use. Apply wipe thoroughly to hands as desired. Allow to dry without wiping.
Disposal. Dispose of used wipes in trash receptacle after use. Do not flush.
Recent Major Changes
Storage. Store at room temperature.
Dispensing. Lift lid and open seal band. Pull up center sheet and pull through the lid. Close lid to retain moisture.
Use. Apply wipe thoroughly to hands as desired. Allow to dry without wiping.
Disposal. Dispose of used wipes in trash receptacle after use. Do not flush.
Other Information
Storage. Store at room temperature.
Please don't keep the package under direct sunlight or at high temperature.
Inactive Ingredients
Water (Aqua), Propylene Glycol, Cocoamidopropyl Betaine, Glyceryl Cocoate, Benzyl Alcohol, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium EDTA, Cetrimonium Chloride, Citric Acid, Fragrance (Perfum)
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