FDA.reportPublic FDA data

JANITEX DISINFECTING WIPES 75% ALCOHOL

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 23:24:50

Label at a glance#

ProductJANITEX DISINFECTING WIPES 75% ALCOHOL
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

To decrease bacteria on the skin that could cause disease

Dosage and administration

• Open container plastic cover. Tear off moisture seal film. Pull out wipe corner from the center of wipe roll; twist wipe corner through the dispensing center of the canister. Next sheets pop up automatically. Keep center cap 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 childr...

Storage and handling

Store in dry and cool place and away from oxidizers.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75 %

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 container plastic cover. Tear off moisture seal film. Pull out wipe corner from the center of wipe roll; twist wipe corner through the dispensing center of the canister. Next sheets pop up automatically. Keep center cap 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, Glycerin, Propylene Glycol, Parfum, Tocopheryl Acetate, Citric Acid, Aloe Barbadensis Extract

SPL UNCLASSIFIED SECTION

75% Alcohol

75% Alcohol Concentration

E Vitamin 

+ moisturizer

non-woven fabric

Bleach Free

Ultra Protection

DISINFECTING WIPES

Distributed by Pacific Health Systems Inc.

19 Commerce Road Unit E Fairfield, NJ 07004

info@janitexus.com www.janitexus.com

Made in Turkey

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1307051ethanol 75 % Medicated PadPSN1
1307051ethanol 0.75 ML/ML Medicated PadSCD1
1307051ethanol 75 % Hand Sanitizer WipesSY1
1307051ethyl alcohol 75 % Topical ClothSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79519-060-012022-01-28C16284748780-1d6a99b39-dff7-a426-e053-dadaa90af4c2JANITEX DISINFECTING ALCOHOL WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79519-060-01JANITEX DISINFECTING WIPES 75% ALCOHOL80 in 1 CANISTERCLOTH801
79519-060-01JANITEX DISINFECTING WIPES 75% ALCOHOL1.83 g in 1 PACKAGECLOTH1.831

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79519-060JANITEX DISINFECTING WIPES 75% ALCOHOL (ETHYL ALCOHOL) CLOTH [PACIFIC HEALTH SYSTEMS INC.]1Legacy NDC, 2 package rows20200815_cfdbb57e-413f-4b63-a200-10d90d314670.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79519-06079519-060-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALOE VERA LEAFZY81Z83H0XIACT

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
b80d9aff-ce7c-40a0-9f9d-2857859c324ccfdbb57e-413f-4b63-a200-10d90d3146702020-08-11WarningsExact identifier
spl id: b80d9aff-ce7c-40a0-9f9d-2857859c324c
spl set id: cfdbb57e-413f-4b63-a200-10d90d314670

Reported adverse events (FAERS/openFDA)#

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