PURELL HAND SANITIZING WIPES- benzalkonium chloride cloth
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 Hand Sanitizing Wipes

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses

Hand sanitizer to help reduce bacteria on the skin

Warnings

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

Wet hands thoroughly with product and allow to dry
Children under 6 years of age should be supervised when using PURELL

Inactive ingredients

Water (Aqua), Decyl Glucoside, Glycerin, Fragrance(Parfum), Phenoxyethanol

Product Label

PURELL HAND SANITIZING WIPES
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21749-368
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:21749-368-35	35 in 1 PACKAGE	03/14/2012	07/01/2022
1		150 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC:21749-368-10	100 in 1 PACKAGE	03/14/2012
2		245 mL in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC:21749-368-27	270 in 1 PACKAGE	03/14/2012
3		667 mL in 1 PACKAGE; Type 0: Not a Combination Product
4	NDC:21749-368-12	1200 in 1 PACKAGE	03/14/2012
4		2567 mL in 1 PACKAGE; Type 0: Not a Combination Product
5	NDC:21749-368-15	1500 in 1 PACKAGE	03/14/2012
5		2674 mL in 1 PACKAGE; Type 0: Not a Combination Product
6	NDC:21749-368-17	1700 in 1 PACKAGE	05/01/2018
6		2273 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/14/2012

Labeler - GOJO Industries, Inc. (004162038)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		036424534	MANUFACTURE(21749-368)