Pro1tek Hand Sanitizer Gel

Pro1tek Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

PRO1TEK HAND SANITIZER- ethyl alcohol 70% gel 
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 is not available

Warnings

For External use only. Flammable. Keep away from heat or flame

Do not use

On 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, propylene glycol 600, carbomer

Pro1tek Hand Sanitizer Gel

PRO1TEK HAND SANITIZER 
ethyl alcohol 70% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52232-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	2649.5 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: 52232-105-58	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2021
2	NDC: 52232-105-59	15140 mL in 1 CASE; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2021	12/01/2022

Labeler - Priority Environmental Solutions Inc. (827067880)

Registrant - Priority Environmental Solutions Inc. (827067880)

Revised: 1/2023

Document Id: f175b817-1f2b-ca09-e053-2a95a90a2f08

34390-5

Set id: b9458b04-480b-619f-e053-2995a90a729a

Version: 2

Effective Time: 20230104