SPL v1
SPL
SPL Set ID cf97930d-040e-4747-8fae-9372b94009fb
Route
TOPICAL
Published
Effective Date 2020-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (80 mL)
Inactive Ingredients
Water Glycerin Hydrogen Peroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-01

Description

Ethyl Alcohol 80% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 80% v/v

Uses

Use on hands and surfaces as a disinfecting agents to kill viruses and bacteria

Section 50565-1

KEEP OUT OF REACH OF CHILDREN If swallowed, seek medical help or contact Poison Control Center right away.

Warnings

For external use only. Flammable. Keep away from heat or flame.

H226 Flammable liquid and vapour.

H319 Causes serious eye irritation.

DO NOT USE on children under the age of 2 months old or open skin wounds

WHEN USING THIS PRODUCT Keep out of eyes, ears and mouth. In case of contact with eyes, rinse thoroughly with water

STOP USE AND ASK A DOCTOR If irritation or rash occur. This may be a sign of a serious condition.

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.

Other Information:

Store between 15-30C (59-85F)

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

Active Ingredient

Ethyl Alcohol 80% v/v

Inactive Ingredients

Deionized Water, Glycerin, Hydrogen Peroxide

Package Label Principal Display Panel

Product label


Structured Label Content

Uses

Use on hands and surfaces as a disinfecting agents to kill viruses and bacteria

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN If swallowed, seek medical help or contact Poison Control Center right away.

Purpose

Antiseptic

Warnings

For external use only. Flammable. Keep away from heat or flame.

H226 Flammable liquid and vapour.

H319 Causes serious eye irritation.

DO NOT USE on children under the age of 2 months old or open skin wounds

WHEN USING THIS PRODUCT Keep out of eyes, ears and mouth. In case of contact with eyes, rinse thoroughly with water

STOP USE AND ASK A DOCTOR If irritation or rash occur. This may be a sign of a serious condition.

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.

Other Information:

Store between 15-30C (59-85F)

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

Active Ingredient

Ethyl Alcohol 80% v/v

Inactive Ingredients (Inactive ingredients)

Deionized Water, Glycerin, Hydrogen Peroxide

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

Product label


Advanced Ingredient Data


Raw Label Data

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