FDA.reportPublic FDA data

JANITEX

Manufacturer
Pacific Health Systems Inc.
Effective date
2020-09-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:28:58

Label at a glance#

ProductJANITEX 75% ALCOHOL WET WIPES
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

• For hand sanitizing to decrease bacteria and germs on skin. • Apply topically to the skin to help prevent cross contamination. • Dries in seconds.

Dosage and administration

• Lift the tab on the top of the lid to open. • Open moisture seal film package before use. • Pull out first wipe through the dispensing center of the canister. Next sheets pops up automatically • Close the lid to retain moisture. • Wipe clean with this product. Let air dry

Storage and handling

• Store at room temperature 15-30℃ (59-86°F). • Lot No. Manufacture date and expiration date can be found on package.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

• For hand sanitizing to decrease bacteria and germs on skin.

• Apply topically to the skin to help prevent cross contamination.

• Dries in seconds.

Warnings

WARNINGS SECTION

• For external use only. Harmful if swallowed.

• Do not use as baby wipes.

• Do not flush down the toilet. 

• Do not use in or contact the eyes.  

Do Not Use

• Highly flammable. Keep away from fire or flame.

• Do not eat or drink when handling

• Avoid contact with open or exposed wounds.

When Using

Keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse eyes thoroughly with water

Stop Use

Stop use if too much skin irritation and sensitivity develops or increases

KEEP OUT OF REACH OF CHILDREN

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• Lift the tab on the top of the lid to open.

• Open moisture seal film package before use.

• Pull out first wipe through the dispensing center of the canister.

Next sheets pops up automatically

• Close the lid to retain moisture.

• Wipe clean with this product. Let air dry

Other Informations

STORAGE AND HANDLING SECTION

• Store at room temperature 15-30℃ (59-86°F).

• Lot No. Manufacture date and expiration date can be found on package.

INACTIVE INGREDIENT SECTION

Inactive Ingredients Aqua, Glycerin, Parfum

SPL UNCLASSIFIED SECTION

ANTIVIRUS

ANTI - FUNGAL

Kills 99.9% Bacteria & Germs

FDA

75% Alcohol Concentration

99.9% Efficient Sterilization

Non-Woven Skin

Moisturizes and Doet Not Dry

BLEACH FREE

Made in Turkey

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

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1307051ethanol 75 % Medicated PadPSN2
1307051ethanol 0.75 ML/ML Medicated PadSCD2
1307051ethanol 75 % Hand Sanitizer WipesSY2
1307051ethyl alcohol 75 % Topical ClothSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79519-020-012022-01-28C16284748780-1d6a99b39-e28b-a426-e053-dadaa90af4c2JANITEX 75% ALCOHOL WIPES
79519-020-022022-01-28C16284748780-1d6a99b39-e28b-a426-e053-dadaa90af4c2JANITEX 75% ALCOHOL WIPES
79519-020-032022-01-28C16284748780-1d6a99b39-e28b-a426-e053-dadaa90af4c2JANITEX 75% ALCOHOL WIPES
79519-020-042022-01-28C16284748780-1d6a99b39-e28b-a426-e053-dadaa90af4c2JANITEX 75% ALCOHOL WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79519-020-01JANITEX75% ALCOHOL WET WIPES4.16 mL in 1 PACKAGECLOTH4.162
79519-020-01JANITEX75% ALCOHOL WET WIPES80 in 1 CANISTERCLOTH802
79519-020-02JANITEX75% ALCOHOL WET WIPES60 in 1 BOXCLOTH602
79519-020-02JANITEX75% ALCOHOL WET WIPES4.16 mL in 1 PACKAGECLOTH4.162
79519-020-03JANITEX75% ALCOHOL WET WIPES40 in 1 PACKETCLOTH402
79519-020-03JANITEX75% ALCOHOL WET WIPES4.16 mL in 1 PACKAGECLOTH4.162
79519-020-04JANITEX75% ALCOHOL WET WIPES80 in 1 CANISTERCLOTH802
79519-020-04JANITEX75% ALCOHOL WET WIPES4.16 mL in 1 PACKAGECLOTH4.162

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79519-020JANITEX 75% ALCOHOL WET WIPES (ETHYL ALCOHOL) CLOTH [PACIFIC HEALTH SYSTEMS INC.]2Legacy NDC, 8 package rows20200910_c8ad48c0-4712-40b3-9abe-1368fbd3777d.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79519-02079519-020-03, 79519-020-02, 79519-020-01, 79519-020-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT

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
44d464ee-8bbd-46c7-b6ac-4afe273037ccc8ad48c0-4712-40b3-9abe-1368fbd3777d2020-09-04WarningsExact identifier
spl id: 44d464ee-8bbd-46c7-b6ac-4afe273037cc
spl set id: c8ad48c0-4712-40b3-9abe-1368fbd3777d

Reported adverse events (FAERS/openFDA)#

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