SPL v1
SPL
SPL Set ID 20391a67-7603-4e15-ad65-8c90806078ef
Route
TOPICAL
Published
Effective Date 2020-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Water Glycerin Trolamine Aminomethylpropanol Denatonium Benzoate Tert-butyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-27

Description

Alcohol 75% v/v

Purpose

antiseptic


Medication Information

Purpose

antiseptic

Description

Alcohol 75% v/v

use

help decrease bacteria on the hands

Section 42229-5

Other information

  • May discolor fabrics or urfaces.
  • Store below 95℉ (35℃).
Warnings

For external use only.

Flammable, Keep away from fire or flame.

Avoid contact with eyes, in case of contact, rinse eyes thoroughly with water immediately.

If irritationdevelops,Discontinue use and consult a doctor.

Packaging

directions
  • Wet hands thoroughly with product and rub lightly until dry. Do not wipe off or rinse.
Active Ingredient

Alcohol 75% v/v

Inactive Ingredients

Purified Water USP, Acrylates Copolymer, Glycerin, Triethanolamine, Aminomethyl Propanol, Denatonium Benzoate, Tert-butyl Alcohol

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

use (Use)

help decrease bacteria on the hands

Section 42229-5 (42229-5)

Other information

  • May discolor fabrics or urfaces.
  • Store below 95℉ (35℃).
Purpose (purpose)

antiseptic

Warnings

For external use only.

Flammable, Keep away from fire or flame.

Avoid contact with eyes, in case of contact, rinse eyes thoroughly with water immediately.

If irritationdevelops,Discontinue use and consult a doctor.

Packaging

directions (Directions)
  • Wet hands thoroughly with product and rub lightly until dry. Do not wipe off or rinse.
Active Ingredient (Active ingredient)

Alcohol 75% v/v

Inactive Ingredients (Inactive ingredients)

Purified Water USP, Acrylates Copolymer, Glycerin, Triethanolamine, Aminomethyl Propanol, Denatonium Benzoate, Tert-butyl Alcohol

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)