Other
Antibacterial Bar Soap for Personal Use
Loles
FDA Label NDC 73485-004
Full FDA labeling including 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 73485-004). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, 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
Otc - Active Ingredient
Benzalkonium Chloride........0.10%
Otc - Purpose
Antimicrobial. Antibacterial Bar Soap.
Indications & Usage
- For washing to decrease bacteria on the skin
- Recommended for repeated use
Warnings
For external use only.
Otc - When Using
When using this product, do not use in or near the eyes. If contact occurs, rinse thorougly with water.
Otc - Stop Use
Stop use and ask doctor if irritation or rash appears and lasts.
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.
Dosage & Administration
- Wet bar with water, wash skin and rinse
Inactive Ingredient
Sodium Palmitate, Sodium Palm Kernelate, Sodium Chloride, Glycerin, Water (aqua), Fragrance (Perfume), Tetrasodium EDTA, Tetrasodium Etidronate, Tocopheryl Acetate (Vitamin E)
Package Label.Principal Display Panel
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