SPL v1
SPL
SPL Set ID b5bf669a-85b3-4637-b601-d119f324926c
Route
TOPICAL
Published
Effective Date 2020-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-24

Description

Ethanol 62%

Purpose

Purpose: Antiseptic


Medication Information

Purpose

Purpose: Antiseptic

Description

Ethanol 62%

Use

 Hand sanitizing to help reduce bacteria on the skin

Section 50565-1

 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Warnings

 For external use only.

 Flammable, keep away from fire or flame.

 When using this product, avoid contact with the eyes. In case of contact, rinse eyes thoroughly with water.

 Stop use and ask a doctor if irritation or redness appears and lasts.

Directions

 Take suitable amount of sanitizer in the hand. Wet thoroughly and rub hands together until dry

Other Information

 Store in room temperature 0~30℃

 Period of Use: 36 Months after manufacturing date

 Manufacturing Date and No. Printed on bottle

Active Ingredient(s)

Ethanol 62%

Inactive Ingredients

Water(Aqua), Carbomer, Triethanolamine, Polyoxyethylene Hydrogenated Caster Oil, Green Tea Extract, Aloe Extract, Tocopheryl Acetate, Fragrance(Parfum)

Package Label Principal Display Panel


Structured Label Content

Use

 Hand sanitizing to help reduce bacteria on the skin

Section 50565-1 (50565-1)

 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Purpose

Purpose: Antiseptic

Warnings

 For external use only.

 Flammable, keep away from fire or flame.

 When using this product, avoid contact with the eyes. In case of contact, rinse eyes thoroughly with water.

 Stop use and ask a doctor if irritation or redness appears and lasts.

Directions

 Take suitable amount of sanitizer in the hand. Wet thoroughly and rub hands together until dry

Other Information (Other information)

 Store in room temperature 0~30℃

 Period of Use: 36 Months after manufacturing date

 Manufacturing Date and No. Printed on bottle

Active Ingredient(s)

Ethanol 62%

Inactive Ingredients (Inactive ingredients)

Water(Aqua), Carbomer, Triethanolamine, Polyoxyethylene Hydrogenated Caster Oil, Green Tea Extract, Aloe Extract, Tocopheryl Acetate, Fragrance(Parfum)

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


Advanced Ingredient Data


Raw Label Data

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