PURELL HEALTHCARE HEALTHY SP 0.5 BAK ANTIMICROBIAL FOAM- benzalkonium chloride liquid

PURELL Healthcare HEALTHY SP 0.5 BAK Antimicrobial Foam by

Drug Labeling and Warnings

PURELL Healthcare HEALTHY SP 0.5 BAK Antimicrobial Foam by is a Otc medication manufactured, distributed, or labeled by GOJO Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium Chloride 0.5%

Purpose

Antimicrobial

Uses

Handwash to help decrease bacteria on the skin

Recommended for repeated use

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

Apply a small amount of product and work into a lather

Rinse well and dry hands completely

Inactive Ingredients

Water (Aqua), Propanediol, Glycerin, Cocamidopropyl Betaine, PEG-80 Sorbitan Laurate, Citric Acid, Ethylhexylglycerin, Lauramine Oxide, Polyquaternium-10, Trisodium Ethylenediamine Disuccinate, Fragrance (Parfum), Phenoxyethanol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PURELL HEALTHCARE HEALTHY SP 0.5 BAK ANTIMICROBIAL FOAM 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21749-687
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	0.005 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
Glycerin (UNII: PDC6A3C0OX)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
PEG-80 Sorbitan Laurate (UNII: 239B50Y732)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Ethylhexylglycerin (UNII: 147D247K3P)
Lauramine Oxide (UNII: 4F6FC4MI8W)
POLYQUATERNIUM-10 (10000 MPA.S AT 2%) (UNII: PI1STR9QYH)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21749-687-40	1200 mL in 1 PACKAGE; Type 0: Not a Combination Product	06/15/2019
2	NDC: 21749-687-42	1250 mL in 1 PACKAGE; Type 0: Not a Combination Product	06/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/15/2019

Labeler - GOJO Industries, Inc. (004162038)

Establishment
Name	Address	ID/FEI	Business Operations
GOJO Industries, Inc.		036424534	manufacture(21749-687)

Establishment
Name	Address	ID/FEI	Business Operations
GOJO Industries, Inc.		088312414	label(21749-687) , pack(21749-687)