PURELL ADVANCED HAND SANITIZER SANITIZING GEL- alcohol gel
GOJO Industries, 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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PURELL Advanced Hand Sanitizer Sanitizing Gel

Active ingredient

Ethyl alcohol 70% 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), Caprylyl Glycol, Denatonium Benzoate, Glycerin, Isopropyl Myristate, t-Butyl Alcohol, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum)

Product Label

PURELL ADVANCED HAND SANITIZER SANITIZING GEL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21749-900
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:21749-900-08	236 mL in 1 PACKAGE; Type 0: Not a Combination Product	06/01/2020	03/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/01/2020	03/31/2021

Labeler - GOJO Industries, Inc. (004162038)

Revised: 11/2022

Document Id: dcc98a71-7edb-42b6-99b3-cac02303ba5a

Set id: 75352d59-729f-4ee4-a02d-1ecc599e2066

Version: 2

Effective Time: 20221118

GOJO Industries, Inc.