FDA.reportPublic FDA data

AmeriDerm Antibacterial Wash

Manufacturer
SHIELD LINE LLC
Effective date
2025-08-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:10:37

Label at a glance#

ProductAmeriDerm Antibacterial Wash
Active ingredientCHLOROXYLENOL
Label structure8 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Drug Facts Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Parachlorometaxylenol 0.3% w/w

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • Handwash to help reduce bacteria on the skin that potentially can cause disease
  • Recommended for repeat 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 and redness develop or if condition persists for more than 72 hours

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 seconds
  • Rince under running water and dry thoroughly

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric Acid Monohydrate, Cocamidopropyl Betaine, Coco Diethanolamide, Disodium Laureth Sulfosuccinate, Edetate Disodium Anhydrous, Ethylhexyl Glycerin, Fragrance, Glyceryl oleate, PEG-7 Glyceryl Cocoate, Phenoxyethanol, Sodium Laureth 3 Sulfate, Sulisobenzone, Water

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG FACT PANELDRUG FACT PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52410-8073-22025-08-15C16284748780-11030e365-0d01-111a-e063-dadaa90a10e2AMERIDERM Antibacterial Foaming - ALL-211
52410-8073-42025-08-15C16284748780-11030e365-0d01-111a-e063-dadaa90a10e2AMERIDERM Antibacterial Foaming - ALL-211
52410-8073-22024-01-30C16284748780-11030e365-0d01-111a-e063-dadaa90a10e2AMERIDERM Antibacterial Foaming - ALL-211
52410-8073-42024-01-30C16284748780-11030e365-0d01-111a-e063-dadaa90a10e2AMERIDERM Antibacterial Foaming - ALL-211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52410-8073-2AmeriDerm Antibacterial Wash1000 mL in 1 POUCHLIQUID10005
52410-8073-4AmeriDerm Antibacterial Wash3780 mL in 1 BOTTLE, PLASTICLIQUID37805

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
52410-807352410-8073-2, 52410-8073-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
DISODIUM LAURETH SULFOSUCCINATED6DH1DTN7EIACT
GLYCERYL OLEATE4PC054V79PIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SULISOBENZONE1W6L629B4KIACT
WATER059QF0KO0RIACT
CHLOROXYLENOL0F32U78V2QACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCO DIETHANOLAMIDE92005F972DIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
ISOPROPYL ALCOHOLND2M416302IACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
EDETATE DISODIUM7FLD91C86KIACT

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
AmeriDerm Antibacterial WashPARACHLOROMETAXYLENOLSHIELD LINE LLC6e652a7d-76bb-bb2d-e053-2a91aa0aac502025-08-15WarningsExact identifier
ndc (package): 52410-8073-2
ndc (package): 52410-8073-4
ndc (product): 52410-8073
ndc11 (package): 52410807304
ndc11 (package): 52410807302
spl id: 3c6a68f1-371f-9027-e063-6294a90a7af8
spl set id: 6e652a7d-76bb-bb2d-e053-2a91aa0aac50

Reported adverse events (FAERS/openFDA)#

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