Active Ingredient
Benzalkonium Chloride 3.0% (w/v)
Delphis Eco
FDA Label NDC 81560-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Delphis Eco Limited for the product Delphis Eco (NDC 81560-002). 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, purpose, uses, warning, otc - 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
Uses
- Hand sanitiser to help reduce bacteria that potentially can cause disease.
- For use when soap and water are not available.
Warning
- For external use only.
Otc - Do Not Use
Do not use
- on 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. Do not ingest. 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.
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
- Place enough product on hands to cover all surfaces.
- Should be applied regularly.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information Or Comments
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
Aloe Barbadensis, Cocamide DEA, Cocamine Oxide, Didecyldimonium chloride, Fragrance, Propylene glycol, Water
Principal Display Panel
Delphis Eco Hand Sanitiser (100 mL) NDC: 81560-001-01
Delphis Eco Hand Sanitising Spray (500 mL) NDC: 81560-002-05
Delphis Eco Hand Sanitising Spray (700 mL) NDC: 81560-002-07
Delphis Eco Hand Sanitising Foam (5 L) NDC: 81560-003-50
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