FDA.reportPublic FDA data

AMERIWASH

Manufacturer
SHIELD LINE LLC
Effective date
2025-08-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:10:37

Label at a glance#

ProductAMERIWASH
Active ingredientCHLOROXYLENOL
Label structure10 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 Apply a small amount of product and work into lather Rinse well and dry hands completely

Label contents#

Full prescribing information#

Drug FactsActive Ingredient

OTC - ACTIVE INGREDIENT SECTION

Parachlorometaxylenol 0.3% w/w

Purpose

OTC - PURPOSE SECTION

Antimicrobial

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

When using this product

OTC - WHEN USING SECTION

  • Do not use in or near the eyes
  • Incase of eye contact rinse the eyes thoroughly with water

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Irritation or rash appears or lasts

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
  • Apply a small amount of product and work into lather
  • Rinse well and dry hands completely

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alpha Hexylcinnamaldehyde, Citric Acid Monohydrate, Cocamidopropyl Betaine, Coco Diethanolamide, D&C Red No. 33, DMDM Hydantoin, Edetate Disodium Anhydrous, FD&C Yellow No.5, FD&C Yellow No.6, PEG-7 Glyceryl Cocoate, Sodium Chloride, Sodium, Laureth Sulfate, Sulisobenzone, Water

AMERIWASH DRUG FACT PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display & Drug Fact PanelPrincipal Display & Drug Fact Panel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52410-8038-32025-08-15C16284748780-11030e365-0fdd-111a-e063-dadaa90a10e2AMERIDERM AMERIWASH PCMX 0.3%
52410-8038-42025-08-15C16284748780-11030e365-0fdd-111a-e063-dadaa90a10e2AMERIDERM AMERIWASH PCMX 0.3%
52410-8038-52025-08-15C16284748780-11030e365-0fdd-111a-e063-dadaa90a10e2AMERIDERM AMERIWASH PCMX 0.3%
52410-8038-32024-01-30C16284748780-11030e365-0fdd-111a-e063-dadaa90a10e2AMERIDERM AMERIWASH PCMX 0.3%
52410-8038-42024-01-30C16284748780-11030e365-0fdd-111a-e063-dadaa90a10e2AMERIDERM AMERIWASH PCMX 0.3%
52410-8038-52024-01-30C16284748780-11030e365-0fdd-111a-e063-dadaa90a10e2AMERIDERM AMERIWASH PCMX 0.3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52410-8038-3AMERIWASH800 mL in 1 POUCHLIQUID8004
52410-8038-4AMERIWASH1000 mL in 1 POUCHLIQUID10004
52410-8038-5AMERIWASH3780 mL in 1 BOTTLELIQUID37804

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52410-803852410-8038-3, 52410-8038-4, 52410-8038-5

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
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCO DIETHANOLAMIDE92005F972DIACT
DMDM HYDANTOINBYR0546TOWIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
WATER059QF0KO0RIACT
CHLOROXYLENOL0F32U78V2QACTIB
D&C RED NO. 339DBA0SBB0LIACT
SULISOBENZONE1W6L629B4KIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT

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
AMERIWASHPARACHLOROMETAXYLENOLSHIELD LINE LLC6d5ed0f9-fb48-7855-e053-2991aa0a18a82025-08-15WarningsExact identifier
ndc (package): 52410-8038-5
ndc (package): 52410-8038-3
ndc (package): 52410-8038-4
ndc (product): 52410-8038
ndc11 (package): 52410803804
ndc11 (package): 52410803803
ndc11 (package): 52410803805
spl id: 3c6a878d-e96d-8fd1-e063-6294a90a7712
spl set id: 6d5ed0f9-fb48-7855-e053-2991aa0a18a8

Reported adverse events (FAERS/openFDA)#

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