SPL v1
SPL
SPL Set ID 6f723843-e6eb-4e40-bb4b-c51f38139d66
Route
TOPICAL
Published
Effective Date 2020-05-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Glycerin Water Carbomer 934 Alpha-tocopherol Acetate Trolamine Aloe Vera Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-22

Description

NA

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

NA

Use

Helps reducing bacteria that potentially can cause disease

Recommended for repeated use

Section 42229-5

NA

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 redness develops and lasts for more than 72 hours

Section 50567-7

When using this product do not use in or near eyes. In case of eye contact, flush eyes thoroughly with water.

Section 51945-4

Warnings

For external use only

Flammable. Keep away from fire or flame

Directions

Place enough product in your palm to thoroughly cover your hands.

Rub hands together briskly untill dry

Children under six years of age should be supervised when using this product

Other Information

Store below 110F (43C)

May discolor certain fabrics or surfaces

Active Ingredient(s)

Ethyl Alcohol 62%

Inactive Ingredients

Water, aloe barbadensis gel, carbomer, fragrance, glycerin, triethanolamine, tocopheryl acetate


Structured Label Content

Use

Helps reducing bacteria that potentially can cause disease

Recommended for repeated use

Section 42229-5 (42229-5)

NA

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 redness develops and lasts for more than 72 hours

Section 50567-7 (50567-7)

When using this product do not use in or near eyes. In case of eye contact, flush eyes thoroughly with water.

Section 51945-4 (51945-4)

Purpose

Antimicrobial

Warnings

For external use only

Flammable. Keep away from fire or flame

Directions

Place enough product in your palm to thoroughly cover your hands.

Rub hands together briskly untill dry

Children under six years of age should be supervised when using this product

Other Information (Other information)

Store below 110F (43C)

May discolor certain fabrics or surfaces

Active Ingredient(s)

Ethyl Alcohol 62%

Inactive Ingredients (Inactive ingredients)

Water, aloe barbadensis gel, carbomer, fragrance, glycerin, triethanolamine, tocopheryl acetate


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)