SPL v1
SPL
SPL Set ID 681698e7-3ec7-4093-83e3-e30d8e6e1245
Route
TOPICAL
Published
Effective Date 2020-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Aloe Vera Leaf Glycerin Isopropyl Myristate Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-10-31

Description

Ethyl Alcohol 70% v/v.

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70% v/v.

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 50567-7

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

Stop use and ask a doctor if irritation occurs. 

Section 50570-1

Do not use on open skin wounds.

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.
  • Do not use other than directed.
Active Ingredient

Ethyl Alcohol 70% v/v.

Other Information
  • Store between 15-30°C (59-86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)
Inactive Ingredients

Aqua/Water/Eau, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Fragrance/Parfum, Glycerin, Isopropyl Myristate, Triethanolamine.

Package Label Principal Display Panel


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 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.

Stop use and ask a doctor if irritation occurs. 

Section 50570-1 (50570-1)

Do not use on open skin wounds.

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.
  • Do not use other than directed.
Active Ingredient

Ethyl Alcohol 70% v/v.

Other Information (Other information)
  • Store between 15-30°C (59-86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)
Inactive Ingredients (Inactive ingredients)

Aqua/Water/Eau, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Fragrance/Parfum, Glycerin, Isopropyl Myristate, Triethanolamine.

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


Advanced Ingredient Data


Raw Label Data

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