80082-201

80082-201
SPL v1
SPL
SPL Set ID ac248267-03cd-2712-e053-2a95a90a8d71
Route
TOPICAL
Published
Effective Date 2020-08-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (65 mL)
Inactive Ingredients
Chinese Cinnamon Trolamine Green Tea Leaf Chamaecyparis Lawsoniana Wood Oil Water Glycerin Propylene Glycol Carbomer Homopolymer, Unspecified Type Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-19

Description

Ethanol 65%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethanol 65%

Use

Hand clean sanitizer to help reduce bacteria on skin

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry.

Children under 6 years of age should be supervised when using this product.

Package Label

Active Ingredient

Ethanol 65%

Other Information

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

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

Inactive Ingredients

Water, Glycerin, Propylene glycol, Carbomer, Aloe Vera gel Triethanolamine, Cinnamomum Cassia Bark Extract, Camellia Sinensis Leaf Extract, Chamaecyparis Lawsoniana Wood Oil

When Using This Product

do not use in or near the eyes, ears and mouth. In case of contact, rinse eyes thoroughly with water.

Stop Use and Ask A Doctor If

irritation or rash appears and last.

Keep Out of Reach of Children.

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


Structured Label Content

Use

Hand clean sanitizer to help reduce bacteria on skin

Purpose

Antiseptic

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry.

Children under 6 years of age should be supervised when using this product.

Package Label

Active Ingredient (Active ingredient)

Ethanol 65%

Other Information (Other information)

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

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

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Propylene glycol, Carbomer, Aloe Vera gel Triethanolamine, Cinnamomum Cassia Bark Extract, Camellia Sinensis Leaf Extract, Chamaecyparis Lawsoniana Wood Oil

When Using This Product (When using this product)

do not use in or near the eyes, ears and mouth. In case of contact, rinse eyes thoroughly with water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation or rash appears and last.

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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