SPL v2
SPL
SPL Set ID a3fc0b3b-9250-35d2-e053-2a95a90afa96
Route
TOPICAL
Published
Effective Date 2020-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (80 L)
Inactive Ingredients
Lauryl Lactate Isopropyl Myristate Cetyl Lactate Hydroxypropyl Cellulose, Unspecified Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-23

Description

Ethyl Alcohol 80% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 80% v/v

Uses

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

Section 50566-9

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

Section 50567-7

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water

Section 50570-1

Do not use in children less than 2 months of age. Do not use on open skin wounds.

Section 51945-4

Alcohol

Hand Sanitizer

with

Premium Skin Conditioners and Moisturizers

Contains

Ethyl Alcohol 80%

PRD# 99000736

Lot# 0040205

Expiry 04/2022

Net Contents: 4L

GenesisHealth

Warnings

For external use only. Flammable. Keep away from source of heat, fire, or flame.

Directions

Place enough product in your palm to thoroughly cover your hands and rub hands together until dry.

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

Active Ingredient

Ethyl Alcohol 80% v/v

Other Information

Store at a temperature below 43C (110F).

May discolor certain fabrics or surfaces.

Inactive Ingredients

Water, Hydroxypropylcellulose (naturally derived), Glycerin, Isopropyl Myristate, Lauryl Lactate, Cetyl Lactate.


Structured Label Content

Uses

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water

Section 50570-1 (50570-1)

Do not use in children less than 2 months of age. Do not use on open skin wounds.

Section 51945-4 (51945-4)

Alcohol

Hand Sanitizer

with

Premium Skin Conditioners and Moisturizers

Contains

Ethyl Alcohol 80%

PRD# 99000736

Lot# 0040205

Expiry 04/2022

Net Contents: 4L

GenesisHealth

Purpose

Antiseptic

Warnings

For external use only. Flammable. Keep away from source of heat, fire, or flame.

Directions

Place enough product in your palm to thoroughly cover your hands and rub hands together until dry.

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

Active Ingredient (Active ingredient)

Ethyl Alcohol 80% v/v

Other Information (Other information)

Store at a temperature below 43C (110F).

May discolor certain fabrics or surfaces.

Inactive Ingredients (Inactive ingredients)

Water, Hydroxypropylcellulose (naturally derived), Glycerin, Isopropyl Myristate, Lauryl Lactate, Cetyl Lactate.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)