PURELL ADVANCED HAND SANITIZER PRIME DEFENSE- alcohol gel 
GOJO Industries, Inc.

----------

PURELL® Advanced Hand Sanitizer PRIME DEFENSE™

Active ingredient

Ethyl alcohol 85% v/v

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

· Place enough product in your palm to thoroughly cover your hands

· Rub hands together briskly until dry

· Children under 6 years of age should be supervised when using this product.

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, Caprylyl Glycol, Glycerin, Isopropyl Myristate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol

Product Front Label
Product Drug Facts Label
Product Back Label
PURELL ADVANCED HAND SANITIZER PRIME DEFENSE 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21749-905
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL85 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21749-905-04118 mL in 1 PACKAGE; Type 0: Not a Combination Product11/17/2020
2NDC:21749-905-12354 mL in 1 PACKAGE; Type 0: Not a Combination Product12/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM505G(a)(3)11/17/2020
Labeler - GOJO Industries, Inc. (004162038)
Establishment
NameAddressID/FEIBusiness Operations
GOJO Industries, Inc.036424534manufacture(21749-905) , pack(21749-905) , label(21749-905)

Revised: 12/2020
Document Id: 9eead74b-66b1-4ebe-9b69-592e6455b144
Set id: 9962349e-ed78-4b22-be00-e38ab0c55dfe
Version: 2
Effective Time: 20201218
 
GOJO Industries, Inc.