a40bee0c-25b6-4ea7-8292-d51780319d59

SPL v1
SPL
SPL Set ID a40bee0c-25b6-4ea7-8292-d51780319d59
Route
topical
Published
Effective Date 2020-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (350 mL)
Inactive Ingredients
water benzalkonium chloride glycerin carbomer homopolymer, unspecified type trolamine aloe

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-05-01

Purpose

ANTISEPTIC

Description

ALCOHOL 70% v/v


Medication Information

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.

Uses

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

For use when soap and water are not available.

Purpose

ANTISEPTIC

Directions

• Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

• Supervise children in the use of this product.

Other Information

• Store between 15℃ to 30℃ (59℉ to 86℉)

• Avoid freezing and excessive heat above 40℃ (104℉)

Inactive Ingredients

Water, Benzalkonium chloride, Glycerin, Carbomer, Trolamine, Aloe extract, Flavor

Description

ALCOHOL 70% v/v

Active Ingredient

ALCOHOL 70% v/v

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

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.

Uses

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

For use when soap and water are not available.

Purpose (PURPOSE)

ANTISEPTIC

Directions

• Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

• Supervise children in the use of this product.

Other Information (Other information)

• Store between 15℃ to 30℃ (59℉ to 86℉)

• Avoid freezing and excessive heat above 40℃ (104℉)

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Benzalkonium chloride, Glycerin, Carbomer, Trolamine, Aloe extract, Flavor

Active Ingredient (ACTIVE INGREDIENT)

ALCOHOL 70% v/v

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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