PURELL HEALTHCARE HEALTHY SP 0.5PCT PCMX ANTIMICROBIAL FOAM

Main information

  • Trade name:
  • PURELL HEALTHCARE HEALTHY SP 0.5PCT PCMX ANTIMICROBIAL FOAM- chloroxylenol liquid
  • Composition:
  • CHLOROXYLENOL 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 HEALTHCARE HEALTHY SP 0.5PCT PCMX ANTIMICROBIAL FOAM- chloroxylenol liquid
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Antimicrobial - Handwash to help reduce bacteria on the skin - Recommended for repeated use

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph not final
  • Authorization number:
  • 21749-522-53, 21749-522-89, 21749-522-90
  • Last update:
  • 31-05-2019

Summary of Product characteristics: dosage, interactions, side effects

PURELL HEALTHCARE HEALTHY SP 0.5PCT PCMX ANTIMICROBIAL FOAM-

chloroxylenol 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 Healthcare HEALTHY SOAP 0.5% PCMX Antimicrobial Foam

Active ingredient

Chloroxylenol 0.5%

Purpos e

Antimicrobial

Us e

Handwash to help reduce bacteria on the skin

Recommended for repeated use

Warnings

For external use only

Wwhen 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), Alcohol, Lauric Acid, Ethanolamine, Dipropylene Glycol, Lactic Acid, Poloxamer 124,

Isopropyl Alcohol, Sodium Metabisulfite, Sodium Sulfite, Tetrasodium EDTA, Sodium Sulfate,

Fragrance (Parfum), Methylparaben, Propylparaben

PURELL HEALTHCARE HEALTHY SP 0.5PCT PCMX ANTIMICROBIAL FOAM

chloroxylenol liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:21749 -522

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CHLO RO XYLENO L (UNII: 0 F32U78 V2Q) (CHLOROXYLENOL - UNII:0 F32U78 V2Q)

CHLOROXYLENOL

0 .0 0 5 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

LAURIC ACID (UNII: 116 0 N9 NU9 U)

MO NO ETHANO LAMINE (UNII: 5KV8 6 114PT)

DIPRO PYLENE GLYCO L (UNII: E10 7L8 5C40 )

LACTIC ACID (UNII: 33X0 4XA5AT)

PO LO XAMER 12 4 (UNII: 1S6 6 E28 KXA)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

SO DIUM METABISULFITE (UNII: 4VON5FNS3C)

SO DIUM SULFITE (UNII: VTK0 1UQK3G)

EDETATE SO DIUM (UNII: MP1J8 420 LU)

SO DIUM SULFATE (UNII: 0 YPR6 5R21J)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End Date

1

NDC:21749 -522-53

535 mL in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct

0 7/14/20 17

2

NDC:21749 -522-

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

Pro duc t

0 7/14/20 17

3

NDC:21749 -522-

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

Pro duc t

0 7/14/20 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

0 7/14/20 17

Labeler -

GOJO Industries, Inc. (004162038)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

GOJO Industries, Inc.

GOJO Industries, Inc.

0 36 424534

ma nufa c ture (21749 -522)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

GOJO Industries, Inc.

0 8 8 312414

label(21749 -522) , pack(21749 -522)

Revised: 7/2017