PURELL Advanced Hand Sanitizer Aspen Retreat

Drug Labeling and Warnings

Drug Details [pdf]

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)

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)

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)

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

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, UNSPECIFIED FORM (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; Type 0: Not a Combination Product	11/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/01/2012	07/31/2019

Labeler - GOJO Industries, Inc. (004162038)

Establishment
Name	Address	ID/FEI	Business Operations
GOJO Industries, Inc.		036424534	manufacture(21749-252)

Revised: 12/2018

Document Id: a0f0219a-ea89-407b-b36b-25bca14b8c8f

34390-5

Set id: 91fbb89b-1d1d-44ec-af30-03d396dcca5c

Version: 2

Effective Time: 20181217