PURELL Advanced Hand SanitizerSpongeBob Splash

Drug Labeling and Warnings

Drug Details [pdf]

PURELL ADVANCED HAND SANITIZER SPONGEBOB 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
SpongeBob 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
• Run 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), Ultramarines (CI 77007), Yellow 5 (CI 19140)

PURELL ADVANCED HAND SANITIZER SPONGEBOB SPLASH 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21749-745
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, D- (UNII: A7E6112E4N)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ULTRAMARINE BLUE (UNII: I39WR998BI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21749-745-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/21/2011
2	NDC: 21749-745-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/21/2011
3	NDC: 21749-745-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/21/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/21/2011	07/31/2019

Labeler - GOJO Industries, Inc. (004162038)

Establishment
Name	Address	ID/FEI	Business Operations
GOJO Industries, Inc.		036424534	MANUFACTURE(21749-745)

Revised: 12/2018

Document Id: d0e13576-ac64-4447-99b6-3c503529143a

34390-5

Set id: dfaa6e06-b60a-4ece-9a40-8763832a8965

Version: 2

Effective Time: 20181207