FDA.reportPublic FDA data

Antibacterial

Manufacturer
Inopak, Ltd
Effective date
2020-02-02
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 23:41:59

Label at a glance#

ProductAntibacterial
Active ingredientCHLOROXYLENOL
Label structure9 sections

Dosage and administration

Wet hands with water and dispense sufficient amount of product into cupped palm of hand. Wash both hands thoroughly for 15 minutes. Rinse under running water and dry thoroughly.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Parachlorometaxylenol 0.3%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • Handwash to help reduce bacteria on the skin that potentially can cause disease.
  • Recommended for repeated use.

Warnings

WARNINGS SECTION

  • For external use only
  • Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.
  • Stop use and ask a doctor if irritation or redness develop or if condition persists for more than 72 hours.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of Reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands with water and dispense sufficient amount of product into cupped palm of hand.
  • Wash both hands thoroughly for 15 minutes.
  • Rinse under running water and dry thoroughly.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, D&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, sodium Laureth Sulfate, TEA-Lauryl Sulfate, Water.

Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENCORE™

INDUSTRIAL PRODUCTS

H110 EPI FOAM

Antibacterial Foaming Hand Wash With 0.3% PCMX

1000 ml

(33.9 fl.oz.)

MADE IN THE USA

Encore Industrial Products

3502 Bacor Rd. Houston, TX 77084

1-877-703-3044

www.encoreindustrial.com

Drug Facts

Active Ingredient                                         Purpose

Parachlorometaxylenol 0.3% w/w           Antiseptic

Uses

  • Handwash to help reduce bacteria on the skin that potentially can cause disease.
  • Recommended for repeated use.

Warnings

  • For external use only
  • Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.
  • Stop use and ask a doctor if irritation or redness develop or if condition persists for more than 72 hours.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Wet hands with water and dispense sufficient amount of product into cupped palm of hand.
  • Wash both hands thoroughly for 15 minutes.
  • Rinse under running water and dry thoroughly.

Inactive ingredients: Citric acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, D&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, sodium Laureth Sulfate, TEA-Lauryl Sulfate, Water.

Questions? Call 1-877-703-3044 or visit our website www.encoreindustrial.com

Pouch LabelPouch Label

Case Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENCORE™

INDUSTRIAL PRODUCTS

H110 EPI FOAM

Antibacterial Foaming Hand Wash With 0.3% PCMX

Encore Industrial Products

3502 Bacor Rd. Houston, TX 77084

1-877-703-3044 • www.encoreindustrial.com

MADE IN THE USA

4/1000

Case LabelCase Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58575-50758575-507-01, 58575-507-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLOROXYLENOL0F32U78V2QACTIB
water059QF0KO0RIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
sodium laureth sulfateBPV390UAP0IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
SODIUM CHLORIDE451W47IQ8XIACT
ALCOHOL3K9958V90MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
DITETRACYCLINE TETRASODIUM EDETATEWX0A0IT7K5IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7eee57d7-79a4-498d-937d-3743eae037c3696f710f-3d38-403b-8599-12e5c2f580832020-02-02WarningsExact identifier
spl id: 7eee57d7-79a4-498d-937d-3743eae037c3
spl set id: 696f710f-3d38-403b-8599-12e5c2f58083

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.