SPL v2
SPL
SPL Set ID a48d3fb7-e203-12c7-e053-2a95a90add2c
Route
TOPICAL
Published
Effective Date 2020-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Glycerin Trolamine Carbomer Homopolymer, Unspecified Type Hyaluronate Sodium Green Tea Leaf Butylene Glycol Artemisia Princeps Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-12

Description

Alcohol 62%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 62%

Use[s]

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

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

Package Label

Other Information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Active Ingredient[s]

Alcohol 62%

Inactive Ingredients

Water, Glycerin, Carbomer, Triethanolamine, Sodium Hyaluronate, Butylene Glycol, Camellia Sinensis Leaf Extract, Artemisia Princeps Extract

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 or rash occurs. These may be signs of a serious condition.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use[s]

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

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

Package Label

Other Information (Other information)

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Active Ingredient[s] (Active ingredient[s])

Alcohol 62%

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Carbomer, Triethanolamine, Sodium Hyaluronate, Butylene Glycol, Camellia Sinensis Leaf Extract, Artemisia Princeps Extract

When Using This Product (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 (Stop use and ask a doctor)

if irritation or rash occurs. These may be signs of a serious condition.

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

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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