Active Ingredients
Ethyl Alcohol 71% v/v
Benzalkonium chloride 0.0165% v/v
Dezihand Hand Sanitizer
FDA Label NDC 80133-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ivero D.o.o. for the product Dezihand Hand Sanitizer (NDC 80133-002). 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 ingredients, purpose, use, directions for use, hazard statements, precautionary statements, otc - keep out of reach of children, note, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Use
To reduce harmful bacteria on skin.
Directions For Use
- Apply 3-5mL (approx. 1 tsp) of product to dry hands and wrists and rub until dry (at least 30 seconds). Period required for biocidal effect: 30-60 seconds.
- For external use only.
- Supervise children under 6 years of age when using product to avoid swallowing.
Hazard Statements
- Causes serious eye irritation. Highly flammable liquid and vapor. May cause drowsiness or dizziness.
Precautionary Statements
- Keep out of reach of children.
- Do not use on children less than 2 months of age.
- Do not use on open skin wounds.
- If in eyes, rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do; continue rinsing. If eye irritation persists, get medical advice/attention.
- Avoid breathing dust/fumes/gas/mist/vapors/aerosol.
- Keep away from heat, hot areas, sparks, open flames and other sources of ignition such as smoking.
- Store in a well-ventilated place between 15-30°C (59-86°F). Keep container tightly closed. Dispose of contents/container in accordance with national regulations.
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children.
Note
Read accompanying leaflet before use. Call Poison Control if you feel unwell after use - (800) 222-1222. For additional information, see safety data sheet.
Inactive Ingredients
non-ionic surfactants, glycerin
Hazard Pictogram
Flame (Flame 29061.1548640307.500.750)
Exclamation Mark (Exclam 61447.1548644843.500.750)
Package Label - Principal Display Panel
1000mL NDC: 80133-002-10
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