ProtecTeaV Professional Hand Sanitizer by Inopak, Ltd. ProtecTeaV Pro 8 oz

ProtecTeaV Professional Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

PROTECTEAV PROFESSIONAL HAND SANITIZER- alcohol solution 
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 Pro 8 oz

Drug Facts

Active Ingredient

Ethyl alcohol 75% v/v.

Purpose

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, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

• Stop use and ask a doctor if irritation or 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 wehn 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 hands together until dry..

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

PROTECTEAV PROFESSIONAL HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-322
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
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-322-01	236 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(58575-322)

Revised: 8/2021

Document Id: ca8e4180-f1df-e31d-e053-2995a90a129b

34390-5

Set id: f3d1977e-8075-4bd0-9384-ada1429e3e5b

Version: 4

Effective Time: 20210827

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