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

Purpose

Antiseptic

Description

Ethyl alcohol 75%


Medication Information

Warnings

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

Purpose

Antiseptic

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.

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%).

Description

Ethyl alcohol 75%

Principal Display Panel

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.

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%

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

Warnings

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

Purpose

Antiseptic

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.

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)

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.

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%

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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