79866-004

79866-004
SPL v3
SPL
SPL Set ID ab7d2b17-40da-e090-e053-2a95a90aca55
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

Purpose

Antiseptic

Description

Ethyl Alcohol 75%


Medication Information

Warnings

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

Purpose

Antiseptic

Directions

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

●Discard wipe in trash receptacle after use.

●Do not flush

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)

Inactive Ingredients

Purified water USP

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

Do Not Use

●in children less than 2 months of age.

●on open skin wounds.

Active Ingredient(s)

Ethyl Alcohol 75%

Package Label Principal Display Panel


Structured Label Content

Warnings

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

Purpose

Antiseptic

Directions

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

●Discard wipe in trash receptacle after use.

●Do not flush

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)

Inactive Ingredients (Inactive ingredients)

Purified water USP

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

Do Not Use (Do not use)

●in children less than 2 months of age.

●on open skin wounds.

Active Ingredient(s)

Ethyl Alcohol 75%

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)