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.

­­­­­­­­­­­­­­­­­­­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.

When using this product

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

­­­­­­­­­­­­­­­­­­­­­Directions

Apply a small amount to palm. Bristly rub, covering hand with product until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store between 33 and 110 F.

Inactive Ingredients

Water/Eau/Agua, Glycerin, Polyethylene glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (vitamin E), Isopropyl Alcohol, Carbomer, Triisopropanolamine

Pro1tek Hand Sanitizer Gel

labelPackPack

PRO1TEK HAND SANITIZER GEL 
ethyl alcohol 70% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52232-107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL2650 mL  in 3785 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52232-107-603785 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2022
2NDC:52232-107-614 in 1 CASE08/01/2022
23785 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/01/2022
Labeler - Priority Environmental Solutions Inc. (827067880)
Registrant - Priority Environmental Solutions Inc. (827067880)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company004236139manufacture(52232-107)

Revised: 8/2022
Document Id: e5cfa6da-f9e4-a460-e053-2995a90a75c3
Set id: e5307e6d-53bf-ff68-e053-2a95a90abc20
Version: 2
Effective Time: 20220809
 
Priority Environmental Solutions Inc.