FDA.reportPublic FDA data

Antibacterial

Manufacturer
Inopak, Ltd
Effective date
2020-02-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:42:04

Label at a glance#

ProductAntibacterial
Active ingredientCHLOROXYLENOL
Label structure11 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

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.

Use

OTC - WHEN USING SECTION

  • Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.

Stop Use

OTC - STOP USE SECTION

  • Stop use and ask a doctor if irritation or redness develop or if condition persists for more than 72 hours.

Keep out of children's reach

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, FD&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, Water.

AmeriDerm Individual label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 52410-8073-2

AmeriDerm

Foam Soap

Antiseptic                            1000 ml

Reorder No: 211                (33.8 fl. Oz.)

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, FD&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, Water.

AMO-80723                        Part# ALL-211                     Rev. 1.0

Manufactured for:

Shield Line LLC.

Hackensack, NJ 07601

USA

www.ameriderm.com                   524 10 80723

AmeriDerm individual labelAmeriDerm individual label

AmeriDerm Case label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 52410-8073-2

AmeriDerm

Foam Soap

Antiseptic                            1000 ml

Reorder No: 211                (33.8 fl. Oz.)

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, FD&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, Water.

AMO-80723                        Part# ALL-211                     Rev. 1.0

Manufactured for:

Shield Line LLC.

Hackensack, NJ 07601

USA

www.ameriderm.com                   524 10 80723

REORDER NO:

ALL-211                AMD-80723

FOAMSOAP ANTISEPTIC                                AmeriDerm

Wt:         1000ml (33.8 FL OZ)

Qty:       6 Pouches

Manufactured for: Shield Line LLC, Hackensack, NJ 07601 • Made in USA                20-80723AD-02

1 03 52410 80723 4                         UOM: CS

211-CS

Rev. 1.0

1000 ML PER

          POUCH

6        POUCHES

          PER CASE

AmeriDerm Case labelAmeriDerm Case label

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58575-51258575-512-01, 58575-512-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLOROXYLENOL0F32U78V2QACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCAMIDOPROPYL DIMETHYLAMINEL36BM7DG2TIACT
DMDM HYDANTOINBYR0546TOWIACT
ALCOHOL3K9958V90MIACT
ISOPROPYL ALCOHOLND2M416302IACT
PHENOXYETHANOLHIE492ZZ3TIACT
FD&C RED NO. 4X3W0AM1JLXIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
Water059QF0KO0RIACT

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
9ecd4fcd-53eb-4bd1-a8c5-de6eb916e03baadbdd5b-5faf-433f-b668-a3506e0ceb522020-02-03WarningsExact identifier
spl id: 9ecd4fcd-53eb-4bd1-a8c5-de6eb916e03b
spl set id: aadbdd5b-5faf-433f-b668-a3506e0ceb52

Reported adverse events (FAERS/openFDA)#

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