PURELL PROFESSIONAL HEALTHY SP 0.5PCT BAK ANTIMICROBIAL FOAM

Main information

  • Trade name:
  • PURELL PROFESSIONAL HEALTHY SP 0.5PCT BAK ANTIMICROBIAL FOAM- benzalkonium chloride liquid
  • Composition:
  • Benzalkonium Chloride 0.005 mg in 1 mL
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PURELL PROFESSIONAL HEALTHY SP 0.5PCT BAK ANTIMICROBIAL FOAM- benzalkonium chloride liquid
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Antimicrobial • Handwash to help decrease bacteria on the skin

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph not final
  • Authorization number:
  • 21749-685-20, 21749-685-23, 21749-685-89, 21749-685-90
  • Last update:
  • 01-06-2019

Summary of Product characteristics: dosage, interactions, side effects

PURELL PROFESSIONAL HEALTHY SP 0.5PCT BAK ANTIMICROBIAL FOAM-

benzalkonium chloride liquid

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 Professional HEALTHY SOAP™ 0.5% BAK Antimicrobial Foam

Active ingredient

Benzalkonium Chloride 0.5%

Purpos e

Antimicrobial

Us es

Handwash to help decrease 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

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

PURELL PROFESSIONAL HEALTHY SP 0.5PCT BAK ANTIMICROBIAL FOAM

benzalkonium chloride liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:21749 -6 8 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Benza lko nium Chlo ride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6 JUD5X6 Y)

Benzalko nium Chlo ride

0 .0 0 5 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

GOJO Industries, Inc.

PRO PANEDIO L (UNII: 59 6 5N8 W8 5T)

Glycerin (UNII: PDC6 A3C0 OX)

Co ca mido pro pyl Beta ine (UNII: 5OCF3O11KX)

PEG-8 0 So rbita n La ura te (UNII: 239 B50 Y732)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

Ethylhexylg lycerin (UNII: 147D247K3P)

La ura mine O xide (UNII: 4F6 FC4MI8 W)

PO LYQ UATERNIUM-10 ( 10 0 0 0 MPA.S AT 2 %) (UNII: PI1STR9 QYH)

TRISO DIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9 Q)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End Date

1

NDC:21749 -6 8 5-23 222 mL in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct

10 /15/20 17

2

NDC:21749 -6 8 5-

120 0 mL in 1 PACKAGE; Type 0 : No t a Co mbinatio n

Pro duc t

10 /15/20 17

3

NDC:21749 -6 8 5-

1250 mL in 1 PACKAGE; Type 0 : No t a Co mbinatio n

Pro duc t

0 4/0 2/20 18

4

NDC:21749 -6 8 5-

20 0 0 mL in 1 PACKAGE; Type 0 : No t a Co mbinatio n

Pro duc t

10 /15/20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

10 /15/20 17

Labeler -

GOJO Industries, Inc. (004162038)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

GOJO Industries, Inc.

0 36 424534

ma nufa c ture (21749 -6 8 5)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

GOJO Industries, Inc.

0 8 8 312414

label(21749 -6 8 5) , pack(21749 -6 8 5)

Revised: 4/2018