PURELL Advanced Hand Sanitizer Sanitizing Gel: Package Insert and Label Information

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.

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)

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL

Inactive Ingredients Ingredient Name Strength WATER CAPRYLYL GLYCOL DENATONIUM BENZOATE GLYCERIN ISOPROPYL MYRISTATE TERT-BUTYL ALCOHOL .ALPHA.-TOCOPHEROL ACETATE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) AMINOMETHYLPROPANOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:21749-900-08 236 mL in 1 PACKAGE None

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

Labeler — GOJO Industries, Inc. (004162038)

Revised: 06/2020 GOJO Industries, Inc.