faf85ff4-3d03-40f8-9866-8033a521096c

SPL v1
SPL
SPL Set ID faf85ff4-3d03-40f8-9866-8033a521096c
Route
topical
Published
Effective Date 2020-12-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (75 mL)
Inactive Ingredients
propylene glycol water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-12-24

Purpose

Antiseptic

Description

Alcohol 75% v/v. Purpose: Antiseptic


Medication Information

Warnings

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

Purpose

Antiseptic

Directions

Avoid contact with eyes and mouth.

If allergy occurs,discontinue use and consult with your doctor.

If a child ingests by accident,get medical advice immediately.

Please keep it in a cool and dry place

Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients

1,2 propylene glycol,water

Description

Alcohol 75% v/v. Purpose: Antiseptic

Use

Used to clean and sterilize the surface of human body.

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 a 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.

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

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

Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Package Label Principal Display Panel


Structured Label Content

Warnings

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

Purpose

Antiseptic

Directions

Avoid contact with eyes and mouth.

If allergy occurs,discontinue use and consult with your doctor.

If a child ingests by accident,get medical advice immediately.

Please keep it in a cool and dry place

Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

1,2 propylene glycol,water

Use

Used to clean and sterilize the surface of human body.

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 a 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.

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

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

Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

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


Advanced Ingredient Data


Raw Label Data

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