SPL v1
SPL
SPL Set ID 5173e084-fb0b-437a-a387-dfe908d2191f
Route
TOPICAL
Published
Effective Date 2020-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Glycerin Carbomer Homopolymer, Unspecified Type Trolamine Lemon Oil, Terpeneless Citral

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-01

Description

Ethanol 70% v/v

Purpose

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

Ethanol 70% v/v

Uses

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

Warnings

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

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Do not use

• in children less than 2 months of age

• on open skin wounds

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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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Stop use and ask a doctor if irritation or rash occurs. These may be signs 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.

Active Ingredient

Ethanol 70% v/v

Other Information

• Store between 15-30C (59-86F)

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

Inactive Ingredients

Water, Glycerin, Carbopol, Triethylamine, Lemon peel oil, Limonen, Citral

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

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

Purpose (PURPOSE)

ANTISEPTIC

Warnings (WARNINGS)

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

--------------------------------------------------------------------------------------------------------

Do not use

• in children less than 2 months of age

• on open skin wounds

--------------------------------------------------------------------------------------------------------

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

--------------------------------------------------------------------------------------------------------

Stop use and ask a doctor if irritation or rash occurs. These may be signs 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.

Active Ingredient (ACTIVE INGREDIENT)

Ethanol 70% v/v

Other Information (Other information)

• Store between 15-30C (59-86F)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Glycerin, Carbopol, Triethylamine, Lemon peel oil, Limonen, Citral

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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