Protecteav Hand Sanitizer

Protec Teav Hand Sanitizer by

Drug Labeling and Warnings

Protec Teav Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Inopak, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROTEC TEAV HAND SANITIZER- hand sanitizer liquid 
Inopak, Ltd.

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 Hand Sanitizer

Active Ingredient(s)

Isopropyl 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

Acrylates /C10-30 alkyl acrylate

crosspolymer, aloe vera barbadensis leaf juice, FD&C

Blue #1, green tea extract, tocopheryl acetate,

triethanolamine, water.

Protec TeaV 2 oz

PROTEC TEAV GREEN TEA TECHNOLOGY

NDC: 58575-321-01

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

Questions?

888.483.7775 Monday-Friday 9am-5pm

Protec TeaV 8 oz

PROTEC TEAV GREEN TEA TECHNOLOGY

NDC: 58575-321-02

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

Protec TeaV 1000 ml

PROTEC EAV GREEN TEA TECHNOLOGY

NDC: 58575-321-03

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.

Protec TeaV 1 Gal

PROTEC TEAV GREEN TEA TECHNOLOGY

NDC: 58575-321-04

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

PROTEC TEAV HAND SANITIZER 
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-321
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.0001 mg  in 100 mL
WATER (UNII: 059QF0KO0R)	29.9 mg  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-321-01	59 mL in 1 PACKAGE; Type 0: Not a Combination Product	09/01/2020	08/27/2021
2	NDC: 58575-321-02	236 mL in 1 PACKAGE; Type 0: Not a Combination Product	09/01/2020	08/27/2021
3	NDC: 58575-321-03	1000 mL in 1 PACKAGE; Type 0: Not a Combination Product	09/01/2020	08/27/2021
4	NDC: 58575-321-04	3785 mL in 1 PACKAGE; Type 0: Not a Combination Product	09/01/2020	08/27/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/2020	08/27/2021

Labeler - Inopak, Ltd. (194718243)

Establishment
Name	Address	ID/FEI	Business Operations
Inopak, Ltd.		194718243	manufacture(58575-321)

Revised: 8/2021

Document Id: ca8e36e2-7c00-2516-e053-2a95a90a70d2

34390-5

Set id: 51d262a8-7f55-466d-9d1b-5ceef63e9ab9

Version: 4

Effective Time: 20210827

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