PURELL Advanced Hand Sanitizer Watermelon Splash

Drug Labeling and Warnings

Drug Details [pdf]

PURELL ADVANCED HAND SANITIZER WATERMELON SPLASH- 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 Watermelon Splash

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

Other information

Store below 110°F (43°C)

May discolor certain fabrics or surfaces

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), Red 33 (CI 17200), Ultramarines (CI 77007), Yellow 5 (CI 19140)

PURELL ADVANCED HAND SANITIZER WATERMELON SPLASH 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21749-548
Route of Administration	Topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.70 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)
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: 21749-548-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/01/2013	07/31/2019

Labeler - GOJO Industries, Inc. (004162038)

Establishment
Name	Address	ID/FEI	Business Operations
GOJO Industries, Inc.		036424534	manufacture(21749-548)

Revised: 12/2018

Document Id: 61d84632-dd23-4fdd-aa24-31b90c3d0e22

34390-5

Set id: cb8f2d07-2f4c-4fb4-bea3-51d05384f17c

Version: 2

Effective Time: 20181217