ff17bafb-8b9f-4723-ac85-83cdd811a399

SPL v1
SPL
SPL Set ID ff17bafb-8b9f-4723-ac85-83cdd811a399
Route
topical
Published
Effective Date 2020-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (70 mL)
Inactive Ingredients
water succinic acid

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-07-01

Purpose

ANTISEPTIC

Description

Ethyl 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

•instant hand antiseptic to decrease bacteria on the skin.

•recommended for repeated use.

•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 15-30℃ (59-86℉)

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

Inactive Ingredients

Water, Succinic acid

Description

Ethyl alcohol 70% v/v

Active Ingredient

Ethyl 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

•instant hand antiseptic to decrease bacteria on the skin.

•recommended for repeated use.

•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

• Store between 15-30℃ (59-86℉)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Succinic acid

Active Ingredient (ACTIVE INGREDIENT)

Ethyl 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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