43116-035

43116-035
SPL v3
SPL
SPL Set ID 1a451616-b16e-8aa7-e063-6294a90a26a1
Route
TOPICAL
Published
Effective Date 2024-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-07

Description

Ethyl alcohol 75%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl alcohol 75%

Use

Use[s] for hand-washing to help reduce bacteria that potentally can cause disease. For use when soap and water are not available.

Stop Use

Stop use and ask a doctor if iritation or rash occurs. These maybe signs of a serious condition.

Warnings

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

Ask Doctor

If there is any discomfort during use, please stop using immediately.

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.

Do Not Use

●in children less than 2 months of age

●on open skin wounds

When Using

When using this product keep out of eyes, ears, and mouth, In case of contact

Active Ingredient

Ethyl alcohol 75%

Other Information

●Store between 15- 30C (59-86F)

●Avold freezing and excessive heat above 40C (104F)

Inactive Ingredients

Water (24.9%), Aloe Extract and Vitamin E (0.09%), Fragrance (0.01%)

Principal Display Panel

Keep Oot of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison

Control Center right away.


Structured Label Content

Use

Use[s] for hand-washing to help reduce bacteria that potentally can cause disease. For use when soap and water are not available.

Purpose

Antiseptic

Stop Use

Stop use and ask a doctor if iritation or rash occurs. These maybe signs of a serious condition.

Warnings

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

Ask Doctor

If there is any discomfort during use, please stop using immediately.

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.

Do Not Use (Do not use)

●in children less than 2 months of age

●on open skin wounds

When Using

When using this product keep out of eyes, ears, and mouth, In case of contact

Active Ingredient

Ethyl alcohol 75%

Other Information (Other information)

●Store between 15- 30C (59-86F)

●Avold freezing and excessive heat above 40C (104F)

Inactive Ingredients (Inactive ingredients)

Water (24.9%), Aloe Extract and Vitamin E (0.09%), Fragrance (0.01%)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

Keep out of reach of children. If swallowed, get medical help or contact a Poison

Control Center right away.


Advanced Ingredient Data


Raw Label Data

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