ProtecTeaV Professional Hand Sanitizer by Camellix, LLC / Inopak, Ltd Protecteav Professional

ProtecTeaV Professional Hand Sanitizer by

Drug Labeling and Warnings

ProtecTeaV Professional Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Camellix, LLC, Inopak, Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROTECTEAV PROFESSIONAL HAND SANITIZER- alcohol solution 
Camellix, LLC

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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Protecteav Professional

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product keep out of eyes, ears, 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.

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.

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.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Acrylates /C10-30 alkyl acrylate crosspolymer, green tea extract, triethanolamine, water

ProtecTeaV Pro 8 oz

PROTEC TEAV GREEN TEA TECHNOLOGY

NDC: 58575-322-01

NON-DRYING FORMULA

HAND SANITIZER EC-16

Kills 99.99% Germs

70% Alcohol with EC16*

Aloe Vera

and Vitamin E

Unscented Gently Softens

8 fl oz / 236 mL

Made in USA

U.S. Patents 8076484, 9446017

*EC16 Technology Related Patents

Drug Facts

Active Ingredient                             Purpose

Ethyl alcohol 75% v/v ……………..Antiseptic

Uses 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 if irritation and redness develop or if condition persists more than 72 hours.

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.

Other information Store below 110° F (43° C). May

 discolor certain fabrics or surfaces.

Directions Apply sufficient amount of product to your

palm to cover both hands. Rub until dry.

Inactive Ingredients Acrylates /C10-30 alkyl acrylate

crosspolymer, green tea extract, triethanolamine, water.

PTV80-8                               PTV80-P-8 Rev. 1.0

Distributed by ProtecTeaV, LLC Life Sciences Business Development Center Augusta University 1120 15the Street, CA2133 Augusta, GA 30912-7624

888.483.7775 protecteav.com

PROTECTEAV PROFESSIONAL HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54866-322
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	24.9 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54866-322-01	236 mL in 1 PACKAGE; Type 0: Not a Combination Product	09/01/2020	11/29/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/2020	11/29/2021

Labeler - Camellix, LLC (968429386)

Establishment
Name	Address	ID/FEI	Business Operations
Inopak, Ltd		194718243	manufacture(54866-322)

Establishment
Name	Address	ID/FEI	Business Operations
Camellix, LLC		968429386	label(54866-322)

Revised: 11/2021

Document Id: d1f4c65e-ef08-ba24-e053-2995a90a0957

34390-5

Set id: bf6a5206-0e01-463a-9fb7-5ffcf4f473a4

Version: 2

Effective Time: 20211129