PROTECTEAV: Package Insert and Label Information

PROTECTEAV- alcohol gel
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.

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. Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Sterile distilled water or boiled cold water.

Active Ingredient(s)

Alcohol 70% 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

glycerin, hydrogen peroxide, purified water USP

ProtecTeav Hand Sanitizer 2 oz

ProtecTeaV Hand Sanitizer 2 oz
(click image for full-size original)
GREEN TEA TECHNOLOGY

NDC 54866-321-01

NON-DRYING FORMULA

HAND SANITIZER EC-16

Kills 99.99% Germs

70% Alcohol with EC16*

Aloe Vera

and Vitamin E

Unscented Gently Softens

2 fl oz / 59 mL

Made in USA

U.S. Patents 8076484, 9446017

*EC16 Technology Related Patents

Drug Facts

Active Ingredient Purpose

Ethyl alcohol 70% 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, aloe vera barbadensis leaf juice, FD&C

Blue #1, green tea extract, tocopheryl acetate,

triethanolamine, water.

PTV-2 PTV-C-2 Rev. 1.0

protecteav.com

Distributed by ProtecTeaV, LLC

Life Sciences Business

Development Center

Augusta University

1120 15the Street, CA2133

Augusta, GA 30912-7624

ProtecTeaV Hand Sanitizer 2 oz Bar code
ProtecTeaV Hand Sanitizer 2 oz Bar code

Questions?

888.483.7775 • Monday-Friday 9am-5pm

ProtecTeav Hand sanitizer 8 oz

PROTEC TEAV GREEN TEA TECHNOLOGY

NDC 54866-321-02

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 70% 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, aloe vera barbadensis leaf juice, FD&C

Blue #1, green tea extract, tocopheryl acetate,

triethanolamine, water.

PTV-8 PTV-C-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 Hand Sanitizer 8 oz Bar code

ProtecTeaV Hand Sanitizer 8 oz
(click image for full-size original)

ProtecTeaV Hand Sanitizer 1000 ml

PROTEC TEAV GREEN TEA TECHNOLOGY

NDC 54866-321-03

NON-DRYING FORMULA

Ingredients:

Acrylates /C10-30 alkyl acrylate

crosspolymer, aloe vera barbadensis leaf juice, FD&C

Blue #1, green tea extract, tocopheryl acetate,

triethanolamine, water.

1000 mL.

ProtecTeaV, LLC

888.483.7775

Protecteav.com

Do Not Take Internally.

Caution: Keep Out of

Reach of Children.

ProtecTeaV Hand Sanitizer 1000  ml Bar code

ProtecTeaV Hand Sanitizer 1000  ml
(click image for full-size original)

ProtecTeaV Hand Sanitizer 1 gal

.PROTEC TEAV GREEN TEA TECHNOLOGY

NDC 54866-321-04

NON-DRYING FORMULA

HAND SANITIZER EC-16

Kills 99.99% Germs

70% Alcohol with EC16*

Aloe Vera

and Vitamin E

Unscented Gently Softens

1 gal / 128 fl oz

Made in USA

U.S. Patents 8076484, 9446017

*EC16 Technology Related Patents

Drug Facts

Active Ingredient Purpose

Ethyl alcohol 70% 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, aloe vera barbadensis leaf juice, FD&C

Blue #1, green tea extract, tocopheryl acetate,

triethanolamine, water.

PTV-Gal PTV-C-Gal 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 Hand Sanitizer 1 Gal Bar Code
ProtecTeaV Hand Sanitizer 1 Gal
(click image for full-size original)
PROTECTEAV
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54866-321
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER 29.9 mg in 100 mL
FD&C BLUE NO. 1 .0001 mg in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54866-321-02 60 mL in 1 BOTTLE None
2 NDC:54866-321-01 236 mL in 1 BOTTLE None
3 NDC:54866-321-03 1000 mL in 1 PACKAGE None
4 NDC:54866-321-04 3785 mL in 1 PACKAGE None
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)
Establishment
Name Address ID/FEI Operations
Camellix, LLC 968429386 label (54866-321)
Establishment
Name Address ID/FEI Operations
Inopak, Ltd 194718243 manufacture (54866-321)

Revised: 10/2020 Camellix, LLC

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