Active Ingredient(S)
Benzalkonium Chloride 0.13%
Ultraclean
FDA Label NDC 80374-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Asilnur Kimya Kozmetik Sanayi Ve Ticaret Anonim Sirketi for the product Ultraclean (NDC 80374-101). 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(s), warnings, otc - keep out of reach of children, direction, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antimicrobial
Use(S)
For hand washing to help reduce bacteria and germs on the skin.
Warnings
• For external use only.
• Not edible, Don’t drink.
• Prolonged skin contact may cause temporary irritation.
Do not Use
• in children less than 2 months of age.
• on open skin wounds.
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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.
Direction
• Pump into hands, wet as needed.
• Lather vigorously for at least 15 seconds.
• Wash hands, rinse thoroughly and dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
Store between 59-86°F (15-30°C). Avoid freezing and excessive heat above 104°F (40°C). May discolor certain fabrics and surfaces.
Inactive Ingredients
Aqua, Cocamidopropyl Betaine, Coco-Glucoside, Glycerin, Peg 150 Distearate, Cocomide MIPA,
Sodium Benzoate, Polyquaternium 7, Disodium EDTA, Lime Oil, Phenoxyethanol, Citric Acid,
Tocopheryl Acetate, Panthenol.
Packaging
Image (80374101 50)
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