79545-201

79545-201
SPL v1
SPL
SPL Set ID aa205bed-77df-73c3-e053-2a95a90ac327
Route
TOPICAL
Published
Effective Date 2020-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Propylene Glycol Green Tea Leaf Trolamine Edetate Disodium Anhydrous Water Glycerin Carbomer Homopolymer, Unspecified Type Aloe Vera Leaf West Indian Lemongrass Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-11

Description

Ethyl Alcohol 70%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70%

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Do Not Use

in childern less than 2 months of age

on open skin wounds

Package Label

Active Ingredient

Ethyl Alcohol 70%

Other Information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract, Green Tea Extract, Disodium EDTA, Lemongrass Oil

When Using This Product

keep out of eyes, 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.


Structured Label Content

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Purpose

Antiseptic

Warnings

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

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Do Not Use (Do not use)

in childern less than 2 months of age

on open skin wounds

Package Label

Active Ingredient (Active ingredient)

Ethyl Alcohol 70%

Other Information (Other information)

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract, Green Tea Extract, Disodium EDTA, Lemongrass Oil

When Using This Product (When using this product)

keep out of eyes, and mouth, In case of contact with eyes, rinse eyes thoroughly with water.

Stop Use and Ask A Doctor (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. (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)