SPL v2
SPL
SPL Set ID a922b87a-93fd-de36-e053-2995a90a282b
Route
TOPICAL
Published
Effective Date 2020-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Propylene Glycol .alpha.-tocopherol Acetate Aloe Water Trolamine Carbomer Homopolymer, Unspecified Type Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-28

Description

Ethyl Alcohol 75%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75%

Use

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

Label

Stop Use

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

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 on open skin wounds. in children less than 2 month of age.

Active Ingredient

Ethyl Alcohol 75%

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

Water(Aqua)

Triethanolamine,

Carbomer,

Glycerin,

Propylene glycol,

Aloe barbadensis extract,

Tocopheryl Acetate

When Using This Product

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

Keep Out of Reach of Children

If swallowed, get medical help or conatct a Posion Control Center right away.


Structured Label Content

Use

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

Label

Purpose

Antiseptic

Stop Use (Stop use)

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

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)

Do not use on open skin wounds. in children less than 2 month of age.

Active Ingredient (Active ingredient)

Ethyl Alcohol 75%

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

Water(Aqua)

Triethanolamine,

Carbomer,

Glycerin,

Propylene glycol,

Aloe barbadensis extract,

Tocopheryl Acetate

When Using This Product (When using this product)

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

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or conatct a Posion Control Center right away.


Advanced Ingredient Data


Raw Label Data

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