PURELL ADVANCED HAND SANITIZER ASPEN RETREAT  - 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 Aspen Retreat

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 you 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, Lactose, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Cellulose, Hydroxypropyl Methylcellulose, Fragrance (Parfum), Blue 1 (CI 42090), Red 33 (CI 17200), Ultramarines (CI 77007), Yellow 5 (CI 19140)

Package Label

PURELL® Advanced Hand Sanitizer Aspen Retreat

Kills the Most Germs* *Ounce for ounce outperforms PURELL® original formulations when used on hands as directed

Kills more than 99.99% of most common germs that may make you sick.

Distributed by:

GOJO Industries, Inc.

Akron, OH 44309

Questions? Tel: 1-888-4-PURELL www.PURELL.com

(c)2012.  GOJO Industries, Inc.


Patent Pending

Label

PURELL ADVANCED HAND SANITIZER ASPEN RETREAT  
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21749-252
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.7 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LACTOSE (UNII: J2B2A4N98G)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:21749-252-01 30 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 11/01/2012
Labeler - GOJO Industries, Inc. (004162038)
Establishment
Name Address ID/FEI Business Operations
GOJO Industries, Inc. 036424534 manufacture(21749-252)

Revised: 9/2012
Document Id: 91fbb89b-1d1d-44ec-af30-03d396dcca5c
Set id: 91fbb89b-1d1d-44ec-af30-03d396dcca5c
Version: 1
Effective Time: 20120901
 
GOJO Industries, Inc.