Drug Facts - PROTECTEAV Hand Sanitizer

PROTECTEAV Hand Sanitizer by

Drug Labeling and Warnings

PROTECTEAV Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by DuBois Chemicals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROTECTEAV HAND SANITIZER- alcohol liquid 
DuBois Chemicals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts - PROTECTEAV Hand Sanitizer

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use

To decrease bacteria on the skin that potentially can cause disease. Recommended for repeated use.

Warnings

Flammable, keep away from heat or flame.

For external use only. Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.

Stop use and ask a doctor

Stop use and ask a doctor if irritation and redness develop or if condition persists more than 72 hours.

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. Children should be supervised by an adult when using this product.

Directions

• Apply sufficient amount of product to your palm to cover both hands.
• Rub until dry.

Other information

• Store between 110 F (43 C).
• May discolor certain fabrics or surfaces.

Inactive ingredients

Water (Aqua), Acrylates/C10-30 alkyl acrylate crosspolymer, green tea extract, triethanolamine, Aloe vera barbadensis leaf juice, tocopheryl acetate, FD&C Blue #1.

Package Label - Principal Display Panel

PROTECTEAV HAND SANITIZER

Non-Drying Formula

Green Tea Technology

NDC: 44395-0321-3

Kills 99.99% Germs

70% Alcohol with EC16* Aloe Vera and Vitamin E

EC16

Unscented

Gently Softens

Made in USA

U.S. Patents 8076484, 9446017

*EC16 Technology Related Patents

1 gal / 128 fl oz

Manufactured by DuBois Chemicals, Inc.

Distributed by ProtecTeaV, LLC

Life Sciences Business

Development Center

Augusta University

1120 15th Street, CA2103

Augusta, GA 30912-7624

Exp. Date

Lot No.

888-483-7775

protecteav.com

UPC Code

PTV-Gal

LA-PTV-D-Gal

Rev. 1.0

PROTECTEAV HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44395-0321
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 L  in 1 L

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44395-0321-1	1249.2 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	12/14/2020	12/30/2022
2	NDC: 44395-0321-3	3.785 L in 1 CONTAINER; Type 0: Not a Combination Product	12/14/2020	12/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/14/2020	12/30/2022

Labeler - DuBois Chemicals, Inc. (828235445)

Registrant - DuBois Chemicals, Inc. (828235445)

Establishment
Name	Address	ID/FEI	Business Operations
DuBois Chemicals, Inc.		080219205	manufacture(44395-0321)

Establishment
Name	Address	ID/FEI	Business Operations
DuBois Chemicals, Inc.		828235445	manufacture(44395-0321)

Revised: 1/2022

Document Id: d5def324-8b0f-10e8-e053-2a95a90a89f1

34390-5

Set id: b6728f5d-b704-70f0-e053-2995a90a1a58

Version: 3

Effective Time: 20220118