43116-039

43116-039
SPL v1
SPL
SPL Set ID 323ef469-e37c-00ad-e063-6394a90ab6f7
Route
TOPICAL
Published
Effective Date 2025-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 U)
Inactive Ingredients
Aloe Water Alpha-tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-08

Description

Ethyl alcohol 75%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl alcohol 75%

Use

For hand-washing to help reduce bacteria that potentially can cause disease. For use when

soap and water are not available.

Stop Use

Stop use and ask a doctor if irritation or rash occurs. These maybe signs of a

serious condition.

Warnings

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

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)

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

Inactive Ingredients

Water (24.9%), Aloe Extract and Vitamin E (0.1%).

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

For hand-washing to help reduce bacteria that potentially can cause disease. For use when

soap and water are not available.

Purpose

Antiseptic

Stop Use

Stop use and ask a doctor if irritation or rash occurs. These maybe signs of a

serious condition.

Warnings

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

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)

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

Inactive Ingredients (Inactive ingredients)

Water (24.9%), Aloe Extract and Vitamin E (0.1%).

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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