FDA.reportPublic FDA data

FUBU Antiseptic Hand Sanitizer Wipes

Manufacturer
BEEKMAN INTERNATIONAL INC
Effective date
2021-01-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:37:34

Label at a glance#

ProductFUBU Antiseptic Hand Sanitizer Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Dosage and administration

wet hands thoroughly with product and allow to dry without wiping

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

in the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • 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 thoroughly with product and allow to dry without wiping

Other information

SPL UNCLASSIFIED SECTION

  • Store at room temperature.
  • Keep lid tightly closed when not in use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzoic Acid, C12-15 Pareth 12, Citric Acid, Dehydroacetic Acid, Fragrance, Glycerin, Phenoxyethanol, Water.

Package Labeling: 15 WIPES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Package Labeling: 72 WIPES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label2label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN1
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD1
1038558benzalkonium chloride 0.13 % Topical ClothSY1
1038558benzalkonium chloride 0.13 % Topical SwabSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY1
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY1

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
81321-000-012022-07-29C16284748780-1e4f33bdf-ad2c-d8a0-e053-dadaa90a6e4eFUBU Antiseptic Hand Sanitizer Wipes
81321-000-022022-07-29C16284748780-1e4f33bdf-ad2c-d8a0-e053-dadaa90a6e4eFUBU Antiseptic Hand Sanitizer Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81321-000-01FUBU Antiseptic Hand Sanitizer Wipes1.8 mL in 1 PATCHCLOTH1.81
81321-000-01FUBU Antiseptic Hand Sanitizer Wipes15 in 1 POUCHCLOTH151
81321-000-02FUBU Antiseptic Hand Sanitizer Wipes72 in 1 POUCHCLOTH721
81321-000-02FUBU Antiseptic Hand Sanitizer Wipes3.47 mL in 1 PATCHCLOTH3.471

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81321-000FUBU ANTISEPTIC HAND SANITIZER WIPES (BENZALKONIUM CHLORIDE) CLOTH [BEEKMAN INTERNATIONAL INC]1Legacy NDC, 4 package rows20210130_ba0e28a9-8118-f7ef-e053-2995a90a324d.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
81321-00081321-000-01, 81321-000-02

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
BENZOIC ACID8SKN0B0MIMIACT
C12-15 PARETH-12131316X18LIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DEHYDROACETIC ACID2KAG279R6RIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
ba0e474c-db5f-910f-e053-2995a90a889eba0e28a9-8118-f7ef-e053-2995a90a324d2021-01-29WarningsExact identifier
spl id: ba0e474c-db5f-910f-e053-2995a90a889e
spl set id: ba0e28a9-8118-f7ef-e053-2995a90a324d

Reported adverse events (FAERS/openFDA)#

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