Otc - Active Ingredient
Ethyl Alcohol - 76%
Cleanboss Hand Sanitizing Gel
FDA Label NDC 57362-524
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Innovative Biodefense for the product Cleanboss Hand Sanitizing Gel (NDC 57362-524). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic
Indications & Usage
- To decrease bacteria on skin.
- Recommended for repeated use.
Warnings
For external use only.
Flammable
Keep away from fire or flames.
Otc - When Using
- Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
- Avoid contact with broken skin.
- Do not inhale or ingest.
Otc - Stop Use
- Irritation or redness develops.
- Condition persists for more than 72 hours.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Center right away.
Dosage & Administration
- Wet hands thoroughly with product and allow to dry without wiping.
- For children under 6, use only with adult supervision.
- Not recommended for use on infants.
Other Safety Information
Store at 20-25°C (68-77°F)
Inactive Ingredient
Benzethonium Chloride, Dimethicone, Farnesol, Fragrance, Hydroxypropyl Methylcellulose, Panthenol, PEG-12, Polyaminopropyl Biguanide, Water
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