SPL v2
SPL
SPL Set ID 5af16956-51a6-4394-baa8-914da6eb88fb
Route
TOPICAL
Published
Effective Date 2020-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (350 mL)
Inactive Ingredients
Water Carbomer Homopolymer, Unspecified Type Glycerin Trolamine Allantoin Dexpanthenol Glycyrrhizinate Dipotassium Lavender Oil Asian Ginseng Orange Oil Limonene, (+)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-01

Description

Ethyl Alcohol 70.0%

Purpose

PURPOSE: ANTISEPTIC


Medication Information

Purpose

PURPOSE: ANTISEPTIC

Description

Ethyl Alcohol 70.0%

Uses

Uses

■ Hand sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

Warnings:

Flammable. Keep away from fire and flames.

For external use only.



When using this product • Do not get into eyes. • If contact occurs, rinse eyes thoroughly with water.



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

Directions

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.

Active Ingredient

Ethyl Alcohol 70.0%

Inactive Ingredients

Carbomer, Glycerin, Triethanolamine, Allantoin, Dexpanthenol, Dipotassium Glycyrrhizate, Lavandula Angustifolia (Lavender) Extract, Panax Ginseng Root Extract, Orange Oil, Limonene, Water

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.

Package Label.principal Display Panel


Structured Label Content

Uses

Uses

■ Hand sanitizer to help reduce bacteria that potentially can cause disease.

Purpose (PURPOSE)

PURPOSE: ANTISEPTIC

Warnings (WARNINGS)

Warnings:

Flammable. Keep away from fire and flames.

For external use only.



When using this product • Do not get into eyes. • If contact occurs, rinse eyes thoroughly with water.



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

Directions

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.

Active Ingredient (ACTIVE INGREDIENT)

Ethyl Alcohol 70.0%

Inactive Ingredients (INACTIVE INGREDIENTS)

Carbomer, Glycerin, Triethanolamine, Allantoin, Dexpanthenol, Dipotassium Glycyrrhizate, Lavandula Angustifolia (Lavender) Extract, Panax Ginseng Root Extract, Orange Oil, Limonene, Water

Keep Out of Reach of Children (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.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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