PURELL HAND SANITIZING WIPES CLEAN REFRESHING SCENT- benzalkonium chloride wipe 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 Clean Refreshing Scent

Active ingredient

Benzalkonium Chloride 0.13%

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Use

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 CLEAN REFRESHING SCENT
benzalkonium chloride wipe cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21749-359
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:21749-359-10	10 in 1 PACKAGE	08/01/2014
1		37 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC:21749-359-15	15 in 1 PACKAGE	08/01/2014	02/02/2020
2		64 mL in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC:21749-359-20	20 in 1 PACKAGE	08/01/2014
3		74 mL in 1 PACKAGE; Type 0: Not a Combination Product
4	NDC:21749-359-40	40 in 1 PACKAGE	08/01/2014
4		173 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	08/01/2014

Labeler - GOJO Industries, Inc. (004162038)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		036424534	manufacture(21749-359)