SPL v9
SPL
SPL Set ID 5c3c319f-7ead-6e4a-e053-2a91aa0a7676
Route
TOPICAL
Published
Effective Date 2017-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (63 mL)
Inactive Ingredients
Water Aloe Vera Leaf 2-(perfluorohexyl)ethanol Peg-10 Acrylate/perfluorohexylethyl Acrylate Copolymer Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-01

Description

Ethanol 63%

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Ethanol 63%

Uses

Hand sanitizer to help reduce bacteria on the skin

Recommended for repeated use

Section 51945-4

Warnings

For External Use Only: hands.

Flammable, keep away from fire or flame.

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

Stop use and ask docotr if irritation and redness develops condition persists for more than 72 hours

Keep out of reach of children. If Swallowed, get medical help or contact a Poison Control Center right away.

Directions

Dispense an adequate amount in your palm to cover all surfaces of hands completely

Rub hands together until dry

Supervise children in the use of this product

Do not consume

Active Ingredient

Ethanol 63%

Other Information

Do not store above 100 o F (38 o C)

May discolor some fabrics

Inactive Ingredients

Water, Propylene Glycol, Glycerin, PEG-10 Acrylate/Perfluorohexylethyl Acrylate Copolymer, 2-Perfluorohexylethyl Alcohol, Aloe Barbadensis Leaf Juice (Aloe), Fragrance (Parfum).

Questions Or Comments?

1-813-815-0530 or www.protectuguard.com

Stop Use and Ask Doctor

if irritation and redness develop and persists for more than 72 hours.


Structured Label Content

Uses

Hand sanitizer to help reduce bacteria on the skin

Recommended for repeated use

Section 51945-4 (51945-4)

Purpose

Antimicrobial

Warnings

For External Use Only: hands.

Flammable, keep away from fire or flame.

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

Stop use and ask docotr if irritation and redness develops condition persists for more than 72 hours

Keep out of reach of children. If Swallowed, get medical help or contact a Poison Control Center right away.

Directions

Dispense an adequate amount in your palm to cover all surfaces of hands completely

Rub hands together until dry

Supervise children in the use of this product

Do not consume

Active Ingredient

Ethanol 63%

Other Information

Do not store above 100 o F (38 o C)

May discolor some fabrics

Inactive Ingredients

Water, Propylene Glycol, Glycerin, PEG-10 Acrylate/Perfluorohexylethyl Acrylate Copolymer, 2-Perfluorohexylethyl Alcohol, Aloe Barbadensis Leaf Juice (Aloe), Fragrance (Parfum).

Questions Or Comments? (Questions or comments?)

1-813-815-0530 or www.protectuguard.com

Stop Use and Ask Doctor

if irritation and redness develop and persists for more than 72 hours.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)