SPL v10
SPL
SPL Set ID a4ae26d0-3240-4154-b661-e9c87636b3a6
Route
TOPICAL
Published
Effective Date 2020-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Water Glycerin Propylene Glycol Trolamine Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-30

Description

Ethyl Alcohol 75% 

Purpose

 Antiseptic


Medication Information

Purpose

 Antiseptic

Description

Ethyl Alcohol 75% 

use
  • Hand sanitizer to help decrease bacteria & virus on the skin 
  • Recommended for repeated use.
Section 42229-5

Other information

Store below 42℃(110℉)

Section 50565-1

Children must be supervised in use of this product.

Warnings

For external use only.

Flammable,

Keep away from fire or flame

Do not apply around eyes, do not use in ears and mouth.

When using this product

avoid contact with eyes. In case of contact, flush eyes with water.

Stop use and ask a doctor if

redness or irritation develop and persist for more than 72 hours

Packaging

directions

Pump as needed into your palms and thoroughly spread on both hands. Rub into skin until dry.

Active Ingredient

Ethyl Alcohol 75% 

Inactive Ingredients

Water, Triethanolamine, glycerin, Carbomer


Structured Label Content

use (Use)
  • Hand sanitizer to help decrease bacteria & virus on the skin 
  • Recommended for repeated use.
Section 42229-5 (42229-5)

Other information

Store below 42℃(110℉)

Section 50565-1 (50565-1)

Children must be supervised in use of this product.

Purpose

 Antiseptic

Warnings

For external use only.

Flammable,

Keep away from fire or flame

Do not apply around eyes, do not use in ears and mouth.

When using this product

avoid contact with eyes. In case of contact, flush eyes with water.

Stop use and ask a doctor if

redness or irritation develop and persist for more than 72 hours

Packaging

directions (Directions)

Pump as needed into your palms and thoroughly spread on both hands. Rub into skin until dry.

Active Ingredient (Active ingredient)

Ethyl Alcohol 75% 

Inactive Ingredients (Inactive ingredients)

Water, Triethanolamine, glycerin, Carbomer


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)