PROTECTEAV by Camellix, LLC / Inopak, Ltd PROTECTEAV- alcohol gel

PROTECTEAV by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug FactsActive Ingredient

Ethyl alcohol 70% v/v

Purpose

Antiseptic

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.

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 for more than 72 hours.

Directions

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

Other information

• store below 110°F (43°C).
• May discolor certain fabrics or surfaces.

Inactive Ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer, aloe vera barbadensis leaf juice, epigallocatechin gallate, tocopheryl acetate, triethanolamine, water.

PROTECTEAV™ product Label

NEW!                  54866

PROTECTEAV™

HAND SANITIZER

Contains 70% Alcohol and Lipophilic EGCG*

DEVELOPED BY MICROBIOLOGISTS

KILLS 99.99% GERMS

WITH EGCG, ALOE VERA & VITAMIN E

 Refreshing  Gently Softens

8 FL OZ (236 mL)                                                                        Camellix®

Made in USA     *US Patent 8076484 and 9446017                     Improving Health with Green Tea Technology

Distributed by Camellix, LLC
Life Sciences Business
Development Center
Augusta University
1120 15th Street, CA 2149
Augusta, GA 30912-7624

INGREDIENTS AND APPEARANCE

PROTECTEAV 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54866-321
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54866-321-01	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2016
2	NDC: 54866-321-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/01/2016

Labeler - Camellix, LLC (968429386)

Registrant - Camellix, LLC (968429386)