SPL v1
SPL
SPL Set ID f3745718-1b32-4f44-b29b-6df8c9dbeaec
Route
TOPICAL
Published
Effective Date 2020-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (1 L)
Inactive Ingredients
Glycerin Aloe Vera Leaf Water Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Triethanolamine Lauryl Sulfate Camellia Sinensis Flower Panthenol

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-30

Description

Ethyl Alcohol 70%

Purpose

Antiseptic, Hand Sanitizer


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

Ethyl Alcohol 70%

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.

Section 51945-4

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 70%

Inactive Ingredients

Glycerin, Hydrogen Peroxide, Aloe Vera Extract, Camellia Sinensis Extract, Carbomer, Triethanolamine, Purified water USP


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.

Section 51945-4 (51945-4)

Purpose

Antiseptic, Hand Sanitizer

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 70%

Inactive Ingredients (Inactive ingredients)

Glycerin, Hydrogen Peroxide, Aloe Vera Extract, Camellia Sinensis Extract, Carbomer, Triethanolamine, Purified water USP


Advanced Ingredient Data


Raw Label Data

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