SPL v1
SPL
SPL Set ID 433e58c6-470a-4d6c-9e90-a2eef742e128
Route
TOPICAL
Published
Effective Date 2025-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-30

Description

Ethyl Alcohol 75% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75% v/v

Use

To help reduce bacteria that potentially can cause disease

Section 50570-1

Section 51945-4

Warnings

For external use only; hands, general cleansing.

Does not replace wipes used for medical procedures.

Flammable; keep away from fire or flame.

Do not ingest.

Directions:

Single use wipes for hands.

Close properly after dispensing to maintain purity,as alcohol by its nature evaporates quickly.

Dispose of properly.

DO NOT FLUSH.

Apply thoroughly to hands to cover all surfaces. Rub hands together until dry.

Active Ingredient

Ethyl Alcohol 75% v/v

Other Information

Keep out of light; store at room temperature 59°F-86°F

Inactive Ingredients:

Glycerol, Water.

When Using This Product:

Keep out of eyes. In case of contact with eyes, flush thoroughly with water. 

Avoid contact with broken skin.

Keep Out Ofreach of Children

If swallowed, get medical help or contact a poison control center right away.

Stop Use and Ask A Doctor If

lrritation and redness develop.

Condition persists for more than 72 hours.


Structured Label Content

Use (use)

To help reduce bacteria that potentially can cause disease

Section 50570-1 (50570-1)

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

For external use only; hands, general cleansing.

Does not replace wipes used for medical procedures.

Flammable; keep away from fire or flame.

Do not ingest.

Directions:

Single use wipes for hands.

Close properly after dispensing to maintain purity,as alcohol by its nature evaporates quickly.

Dispose of properly.

DO NOT FLUSH.

Apply thoroughly to hands to cover all surfaces. Rub hands together until dry.

Active Ingredient

Ethyl Alcohol 75% v/v

Other Information

Keep out of light; store at room temperature 59°F-86°F

Inactive Ingredients: (Inactive ingredients:)

Glycerol, Water.

When Using This Product: (When using this product:)

Keep out of eyes. In case of contact with eyes, flush thoroughly with water. 

Avoid contact with broken skin.

Keep Out Ofreach of Children (Keep out ofreach of children)

If swallowed, get medical help or contact a poison control center right away.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

lrritation and redness develop.

Condition persists for more than 72 hours.


Advanced Ingredient Data


Raw Label Data

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