SPL v3
SPL
SPL Set ID 5d9f8f6d-1b15-4f29-8e4c-2c1d7d78e209
Route
TOPICAL
Published
Effective Date 2020-04-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Glycerin Carbomer 934 Water Propylene Glycol .alpha.-tocopherol Acetate Aminomethyl Propanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-26

Description

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 75% v/v. Purpose: Antiseptic

Use

For hand washing to decrease bacteria on the skin

Section 42229-5

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 redness or irritation develops and persist for more than 72 hours

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.

Section 51945-4

Warnings

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

Directions
  • Wash hands thoroughly with product and allow to dry without wiping.
  • Supervise children in the use of this product to avoid swallowing.
Do Not Use

Do not use in the eyes. In case of contatc, rinse eyes thoroughly with water.

Other Information
  • Store between 15-30C (59-86F)
  • May discolor fabrics
Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients

Water, Glycerin, Carbomer, Aminomethyl Propanol, Propylene Glycol, Tocopherol Acetate


Structured Label Content

Use

For hand washing to decrease bacteria on the skin

Section 42229-5 (42229-5)

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 redness or irritation develops and persist for more than 72 hours

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.

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

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

Directions
  • Wash hands thoroughly with product and allow to dry without wiping.
  • Supervise children in the use of this product to avoid swallowing.
Do Not Use (Do not use)

Do not use in the eyes. In case of contatc, rinse eyes thoroughly with water.

Other Information (Other information)
  • Store between 15-30C (59-86F)
  • May discolor fabrics
Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Carbomer, Aminomethyl Propanol, Propylene Glycol, Tocopherol Acetate


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)