79866-001

79866-001
SPL v3
SPL
SPL Set ID ab7c6dfb-68c5-bc58-e053-2995a90aa847
Route
TOPICAL
Published
Effective Date 2020-03-28
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 NOT FINAL Active Since 2020-03-30

Description

Ethyl Alcohol 75%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75%

Use

● Hand sanitizer to help reduce bacteria that potentially cause disease.

●For use when soap and water are not available

Section 50565-1

Keep out of reach of children. If swallowed. get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of serious condition.

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water

Warnings

For external use only. Flammable. keep away from fire or flame.

Directions

● Apply to hands, allow to air dry without wiping .

●Discard wipe in trash receptacle after use.

●Do not flush

Do Not Use

●in children less than 2 months of age.

●on open skin wounds.

Other Information

●Store in a cool, dry place, between 15°-30°C(59°F-86°F)

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

Active Ingredient(s)

Ethyl Alcohol 75%

Inactive Ingredients

Purified water USP

Package Label Principal Display Panel


Structured Label Content

Use

● Hand sanitizer to help reduce bacteria that potentially cause disease.

●For use when soap and water are not available

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed. get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of serious condition.

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water

Purpose

Antiseptic

Warnings

For external use only. Flammable. keep away from fire or flame.

Directions

● Apply to hands, allow to air dry without wiping .

●Discard wipe in trash receptacle after use.

●Do not flush

Do Not Use (Do not use)

●in children less than 2 months of age.

●on open skin wounds.

Other Information (Other information)

●Store in a cool, dry place, between 15°-30°C(59°F-86°F)

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

Active Ingredient(s)

Ethyl Alcohol 75%

Inactive Ingredients (Inactive ingredients)

Purified water USP

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)