SPL v2
SPL
SPL Set ID 4f43f9f0-783c-419f-a038-70c82976cdef
Route
TOPICAL
Published
Effective Date 2021-03-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 g)
Inactive Ingredients
Water Carbomer Homopolymer, Unspecified Type Propylene Glycol Aminomethylpropanol Denatonium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-03-20

Description

Alcohol 70%

Purpose

Antiseptic gel


Medication Information

Purpose

Antiseptic gel

Description

Alcohol 70%

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.

Section 50565-1

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.

Directions

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

Product Label

Active Ingredient

Alcohol 70%

Inactive Ingredients

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

BENZOATE.


Structured Label Content

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.

Section 50565-1 (50565-1)

Purpose

Antiseptic gel

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.

Directions

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

Product Label (Product label)

Active Ingredient

Alcohol 70%

Inactive Ingredients (Inactive ingredients)

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

BENZOATE.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)