FDA.reportPublic FDA data

JANITEX ANTIBACTERIAL WET WIPES

Manufacturer
Pacific Health Systems Inc.
Effective date
2020-08-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:49

Label at a glance#

ProductJANITEX ANTIBACTERIAL WET WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

To decrease bacteria on the skin that could cause disease

Dosage and administration

• Open lid, gently peel back resealable label, remove and use wipes as required. Keep lid closed to prevent moisture loss. • No need to rinse after usage. Allow skin to dry without wiping. • For adults and children 2 years and over. Discard properly after use. • Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store in dry and cool place and away from oxidizers.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride (0.1%)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • To decrease bacteria on the skin that could cause disease

Warnings

WARNINGS SECTION

  • For external use only, harmful if swallowed.
  • Do not use as baby wipe.
  • Do not flush.
  • Do not use on open skin wounds.
  • Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
  • Stop use and ask a doctor if irritation or allergic reaction occurs.
  • Flammable - Keep away from fire or flame

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

• Open lid, gently peel back resealable label, remove and use wipes as required. Keep lid closed to prevent moisture loss.

• No need to rinse after usage. Allow skin to dry without wiping. • For adults and children 2 years and over. Discard properly after use. • Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

STORAGE AND HANDLING SECTION

  • Store in dry and cool place and away from oxidizers.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Phenoxyethanol, Propylene Glycol, Parfum, Cocamidopropyl Betaine, PEG-40 Hydrogenated Castor Oil, Benzoic Acid, Tetrasodium EDTA, Dehydroacetic Acid, Sodium Hydroxide

SPL UNCLASSIFIED SECTION

pH 5.5

E Vitamin

DERMATOLOGICALLY TESTED 

+ moisturizer 

non-woven fabric

Bleach Free

Ultra Protection

ANTIBACTERIAL

Distributed by Pacific Health Systems Inc.

19 Commerce Road Unit E Fairfield, NJ 07004

info@janitexus.com www.janitexus.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038856benzalkonium Cl 0.1 % Medicated PadPSN1
1038856benzalkonium chloride 1 MG/ML Medicated PadSCD1
1038856benzalkonium chloride 0.1 % Medicated WipesSY1
1038856benzalkonium chloride 0.1 % 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
79519-050-012022-01-28C16284748780-1d6a99b39-78d1-a426-e053-dadaa90af4c2JANITEX Antibacterial Wet Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79519-050-01JANITEX ANTIBACTERIAL WET WIPES3.23 g in 1 PACKAGECLOTH3.231
79519-050-01JANITEX ANTIBACTERIAL WET WIPES90 in 1 PACKETCLOTH901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79519-050JANITEX ANTIBACTERIAL WET WIPES (BENZALKONIUM CHLORIDE) CLOTH [PACIFIC HEALTH SYSTEMS INC.]1Legacy NDC, 2 package rows20200815_ba3f957d-b477-4c51-8213-b67bb7c00ab3.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79519-05079519-050-01

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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
BENZOIC ACID8SKN0B0MIMIACT
EDETATE SODIUMMP1J8420LUIACT
DEHYDROACETIC ACID2KAG279R6RIACT
SODIUM HYDROXIDE55X04QC32IIACT

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
1af285fe-6204-449a-b795-3f0924b317e6ba3f957d-b477-4c51-8213-b67bb7c00ab32020-08-11WarningsExact identifier
spl id: 1af285fe-6204-449a-b795-3f0924b317e6
spl set id: ba3f957d-b477-4c51-8213-b67bb7c00ab3

Reported adverse events (FAERS/openFDA)#

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