Hygipart Antiseptc
FDA Label NDC 80214-004

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mod Design Build for the product Hygipart Antiseptc (NDC 80214-004). 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 active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Alcohol 70%

Purpose

Antiseptic gel

Use

Hygipart is an antiseptic gel for hand hygiene and hydration, the effectiveness is 99,99% for
microorganisms: Salmonella choleraesuis, Staphylococcus aureus and Pseudomonas aeruginosa.

Warnings

  Keep out of reach of children.
- This product does not replace soap and water washing.
- Flammable.
- Keep the product in its original packaging and away from heat and flames.
- Do not use in critical hospital areas (surgical areas).
- Do not reuse the empty packaging.
-Store at room temperature (15- 30°C}, away from heat and direct natural light.
- Keep away from fire and heat.
- Do not pierce the cover.
- Don't spill over the fire.
-In case of burn, wash the area with running water.
- In case of ingestion, do not induce vomiting and immediately consult the poison center or the
nearest health service.
- Not ingest- contains denaturant.
-The product contains "Denatonium Benzoate" as a denaturant.

Otc - Keep Out Of Reach Of Children

Directions

Apply a small amount of Hygipart on your hands and spread until completely absorbed.

Inactive Ingredients

CARBOMER, ALCOHOL, PROPYLENE GLYCOL, AMINOMETHYL PROPANOL, AQUA, DENATONIUM
BENZOATE.

Product Label

Image Description (Image 2)

Image Description (Image 2)

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