SPL v1
SPL
SPL Set ID a8b01bbe-864e-c34c-e053-2995a90a48ca
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (80 mL)
Inactive Ingredients
Glycerin Butane .alpha.-tocopherol Aloe Vera Leaf Isobutane Propane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

Ethyl Alcohol 80%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 80%

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Warnings

For external use only. Flammable. Keep away from heat or flame

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Ethyl Alcohol 80%

Inactive Ingredients

Butan, Isobutan, Propan, Glycerin, Aloe Barbadensis Leaf Extract, Vitamin E

Package Label Principal Display Panel

Vitiugen

Anti Bacterial Sprey

Hygenic-Surgical

Alcohol Based

Hand and Skin Antiseptic

It kills 99.9% of the tested bacteria.

It kills the tested bacteria in 1 minute.

It provides antibacterial protection against tested bacteria.

It is formulated in the pH range compatible with the skin.

Pharmest Saglik Urunleri San. ve Tic. Ltd. Sti.

Orhan Gazi Mah. 18. Yol Sok. No: 12 Esenyurt/Istanbul TURKEY


Structured Label Content

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Purpose

Antiseptic

Warnings

For external use only. Flammable. Keep away from heat or flame

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Ethyl Alcohol 80%

Inactive Ingredients (Inactive ingredients)

Butan, Isobutan, Propan, Glycerin, Aloe Barbadensis Leaf Extract, Vitamin E

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Vitiugen

Anti Bacterial Sprey

Hygenic-Surgical

Alcohol Based

Hand and Skin Antiseptic

It kills 99.9% of the tested bacteria.

It kills the tested bacteria in 1 minute.

It provides antibacterial protection against tested bacteria.

It is formulated in the pH range compatible with the skin.

Pharmest Saglik Urunleri San. ve Tic. Ltd. Sti.

Orhan Gazi Mah. 18. Yol Sok. No: 12 Esenyurt/Istanbul TURKEY


Advanced Ingredient Data


Raw Label Data

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