PURELL Advanced Hand Sanitizer Sanitizing Gel

PURELL Advanced Hand Sanitizer Sanitizing Gel by

Drug Labeling and Warnings

PURELL Advanced Hand Sanitizer Sanitizing Gel by is a Otc medication manufactured, distributed, or labeled by GOJO Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 LabelProduct Label

PURELL ADVANCED HAND SANITIZER SANITIZING GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 21749-900
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 21749-900-08236 mL in 1 PACKAGE; Type 0: Not a Combination Product06/01/202003/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/202003/31/2021
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
 
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