FDA.reportPublic FDA data

Unitex Antibacterial Lotion Hand Soap

Manufacturer
Jon-Don LLC | Betco corporation, Ltd.
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:47:00

Label at a glance#

ProductUnitex Antibacterial LotionHandSoap
Active ingredientCHLOROXYLENOL
Label structure9 sections

Indications and uses

​ ​Antibacterial hand cleaner. Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics

Dosage and administration

​Read the entire label before using this product. ​Dispense 2 pumps of product onto palm of hand and scrub thoroughly over all surfaces of both hands. Rinse with clean water.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol 0.40%

Uses

INDICATIONS & USAGE SECTION

  • ​​Antibacterial hand cleaner.
  • Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics

Warnings

WARNINGS SECTION

  • For external use only.
  • Avoid contact with eyes.
  • Children under the age of 6 should be supervised by an adult when using this product.
  • Discontinue use is irritation or redness develops.
  • If irritation persists for more than 72 hours, consult a physician.
  • KEEP OUT OF REACH OF CHILDREN.
  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • ​Read the entire label before using this product.
  • ​Dispense 2 pumps of product onto palm of hand and scrub thoroughly over all surfaces of both hands.
  • Rinse with clean water.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

​Water, Sodium Laureth lSulfate, Cocamidopropyl betadine, Phenoxyethanol, Coco MIPA, Glycol Stearate, DMDM Hydantoin, Propylene Glycol, Sodium Chloride, Fragrance, Glycerin, Ethanol,  D&C Green #5, FD&C Yellow #5.

Purpose

OTC - PURPOSE SECTION

Antibacterial

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Winning Hands Antibacterial

KEEP OUT OF REACH OF CHILDREN

SPL UNCLASSIFIED SECTION

©2017 Betco Corporation
400 Van Camp Road Bowling Green, Ohio 43402
Made In U.S.A. All Rights Reserved.

888-GO BETCO (888-462-3826) | Betco.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20242024141-01141-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1150812chloroxylenol 0.4 % Medicated Liquid SoapPSN2
1150812chloroxylenol 4 MG/ML Medicated Liquid SoapSCD2
1150812chloroxylenol 0.4 % Medicated Liquid SoapSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84955-841-04Unitex Antibacterial LotionHandSoap3780 mL in 1 JUGLIQUID37802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84955-841UNITEX ANTIBACTERIAL LOTIONHANDSOAP (CHLOROXYLENOL) LIQUID [JON-DON LLC]2Current NDC, 1 package rows20241222_20beb8a0-c1cb-e03d-e063-6394a90abefe.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84955-84184955-841-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-AMYLCINNAMALDEHYDEWC51CA3418IACT
.BETA.-CITRONELLOL, (+/-)-565OK72VNFIACT
3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANALL65EG8H6PAIACT
4-ACETOXY-3-PENTYLTETRAHYDROPYRAN30E3255185IACT
SODIUM BENZOATEOJ245FE5EUIACT
2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OLVK5ZHH2T3FIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
2-TERT-BUTYLCYCLOHEXYL ACETATE364FV60913IACT
HEXYL SALICYLATE8F78EY72YLIACT
.GAMMA.-UNDECALACTONEQB1T0AG2YLIACT
SODIUM CHLORIDE451W47IQ8XIACT
D&C GREEN NO. 58J6RDU8L9XIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
LAURIC ISOPROPANOLAMIDE82DUX3RRVUIACT
SODIUM CARBONATE45P3261C7TIACT
GLYCOL DISTEARATE13W7MDN21WIACT
SODIUM HYDROXIDE55X04QC32IIACT
CALCIUM SILICATES4255P4G5MIACT
SODIUM LAURYL SULFATE368GB5141JIACT
LINALOOL, (+/-)-D81QY6I88EIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
SODIUM ALUMINIUM SILICATE058TS43PSMIACT
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CHLOROXYLENOL0F32U78V2QACTIB
COCAMIDOPROPYLAMINE OXIDEM4SL82J7HKIACT
BENZYL ACETATE0ECG3V79ZJIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
1-(2,3,8,8-TETRAMETHYL-1,2,3,4,5,6,7,8-OCTAHYDRONAPHTHALEN-2-YL)ETHANONE1GD7ODM28YIACT
DIHYDROMYRCENOL46L1B02ND9IACT
HEXAHYDRO-4,7-METHANOINDEN-6-YL PROPIONATES3ASM14UASIACT
VERDYL ACETATE5232EN3X2FIACT

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
Unitex Antibacterial LotionHandSoapCHLOROXYLENOLJon-Don LLC20beb8a0-c1cb-e03d-e063-6394a90abefe2024-12-19WarningsExact identifier
ndc (package): 84955-841-04
ndc (product): 84955-841
ndc11 (package): 84955084104
spl id: 29a4493a-c9c6-8dd0-e063-6394a90a31ee
spl set id: 20beb8a0-c1cb-e03d-e063-6394a90abefe

Reported adverse events (FAERS/openFDA)#

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