FDA.reportPublic FDA data

America1 Hand Wipes

Manufacturer
America1ppe LLC
Effective date
2021-06-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:07

Label at a glance#

ProductAmerica1 Hand Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Indications and uses

For handwashing to decrease bacteria on the skin

Dosage and administration

​Storage: Store at room temperature Dispensing: Remove seal band. Lift tab at front of lid. Pull out wipe and reseal lid. Close lid to retain moisture Use: Apply wipe thoroughly to hands as desired. Allow to dry without wiping. Disposal: Dispose of used wipes in trash receptacle after use. Do not flush

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% w/w

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin

Warning

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • In the eyes
  • If you are allergic to any of the ingredients

When using this product

OTC - WHEN USING SECTION

​if eye contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation and redness develops and 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 Posion Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • ​Storage: Store at room temperature
  • Dispensing: Remove seal band. Lift tab at front of lid. Pull out wipe and reseal lid. Close lid to retain moisture
  • Use: Apply wipe thoroughly to hands as desired. Allow to dry without wiping.
  • Disposal: Dispose of used wipes in trash receptacle after use. Do not flush

Other information

SPL UNCLASSIFIED SECTION

Production Date, Expiry Date and  Lot Number on side

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzoic Acid, C12-15 Pareth-12, Dehydroacetic acid, Fragrance, Glycerin, Phenoxyethanol, Purified Water, Tetrasodium Glutamate Diacetate

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 82055-013-90

America1 + ANTIBACTERIAL HAND WIPES

MADE IN USA

KILLS 99.99% OF GERMS*

* Kills 99.9% of germs that may cause illness| 90 wipes. 6.3 in X 7.1 in | Country of Origin: USA

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82055-013-902023-01-30C16284748780-1f386c64a-0d60-0266-e053-dadaa90a7c1aAntibacterial Hand Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82055-013-90America1 Hand Wipes90 in 1 POUCHCLOTH901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82055-013AMERICA1 HAND WIPES (BENZALKONIUM CHLORIDE) CLOTH [AMERICA1PPE LLC]1Legacy NDC, 1 package rows20210630_bda34a73-4352-4484-a412-0d57346bb67d.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82055-01382055-013-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
BENZOIC ACID8SKN0B0MIMIACT
DEHYDROACETIC ACID2KAG279R6RIACT
C12-15 PARETH-12131316X18LIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT

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
02975350-0179-4e5e-8e3a-8b789de8fa17bda34a73-4352-4484-a412-0d57346bb67d2021-06-29WarningsExact identifier
spl id: 02975350-0179-4e5e-8e3a-8b789de8fa17
spl set id: bda34a73-4352-4484-a412-0d57346bb67d

Reported adverse events (FAERS/openFDA)#

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