Pro1tek Hand Sanitizer by Priority Environmental Solutions Inc. Pro1tek Hand Sanitizer

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

Active Ingredient

Ethyl Alcohol 70%

­­­­­­­­­­­­­­­­­­­­­ Purpose

Antimicrobial

Uses

Hand Sanitizer to help reduce bacteria on hands when soap and water are not available. Recommended for repeated use

Warnings

FLAMMABLE. Keep away from fire or flame.

For External Use Only.

When using this product

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

Do not use

On children less than 2 months of age. On open skin wounds.

­­­­­­­­­­­­­­­­­­­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

Inactive Ingredients

Glycerol, Hydrogen peroxide, Purified water

Other Information

Store between 15-30C (59-86F).

Avoid freezing and excessive heat above 40C (104F)

Pro1tek Hand Sanitizer

PRO1TEK HAND SANITIZER 
ethyl alcohol 70% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52232-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	350 mL  in 500 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCEROL FORMAL (UNII: 3L7GR2604E)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52232-103-54	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
2	NDC: 52232-103-55	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
3	NDC: 52232-103-57	3600 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/01/2020	06/30/2023

Labeler - Priority Environmental Solutions Inc. (827067880)

Registrant - Priority Environmental Solutions Inc. (827067880)

Revised: 7/2023

Document Id: 0024a56b-46fa-c44e-e063-6294a90abd52

34390-5

Set id: a6b7587d-83cd-fab5-e053-2a95a90a7619

Version: 4

Effective Time: 20230710