Pro1tek Hand Sanitizer Gel

Pro1tek Hand Sanitizer Gel by

Drug Labeling and Warnings

Pro1tek Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Priority Environmental Solutions Inc., Prime Eco Group, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRO1TEK HAND SANITIZER GEL- ethyl alcohol 70% liquid 
Priority Environmental Solutions Inc.

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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Pro1tek Hand Sanitizer Gel

Active Ingredient

Ethyl Alcohol 70%

­­­­­­­­­­­­­­­­­­­­­ Purpose

Antiseptic

Uses

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.

­­­­­­­­­­­­­­­­­­­­­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

Purified Water, Glycerin USP, Polyethylene glycol 600, Carbomer

Pro1tek Hand Sanitizer Gel

PRO1TEK HAND SANITIZER GEL 
ethyl alcohol 70% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52232-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	2650 mL  in 3785 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52232-106-58	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2022	06/06/2022
2	NDC: 52232-106-59	15140 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2022	06/06/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/01/2022	06/06/2022

Labeler - Priority Environmental Solutions Inc. (827067880)

Registrant - Priority Environmental Solutions Inc. (827067880)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Eco Group, Inc		097411727	manufacture(52232-106)

Revised: 8/2022

Document Id: e727e2bd-449a-1259-e053-2a95a90acae9

34390-5

Set id: d9b9a1f7-18df-c330-e053-2a95a90aeeee

Version: 2

Effective Time: 20220826