Antibacterial Skin Cleanser

Manufacturer
Betco Corporation, Ltd.
Effective date
2020-09-11
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 23:15:36

Label at a glance#

ProductAntibacterial Skin Cleanser
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 0.375%

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

292919191010888804045555

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65601-708-042024-10-01C16284748780-11030e365-6afd-111a-e063-dadaa90a10e2Antibacterial Skin Cleanser
65601-708-102024-10-01C16284748780-11030e365-6afd-111a-e063-dadaa90a10e2Antibacterial Skin Cleanser
65601-708-192024-10-01C16284748780-11030e365-6afd-111a-e063-dadaa90a10e2Antibacterial Skin Cleanser
65601-708-292024-10-01C16284748780-11030e365-6afd-111a-e063-dadaa90a10e2Antibacterial Skin Cleanser
65601-708-412024-10-01C16284748780-11030e365-6afd-111a-e063-dadaa90a10e2Antibacterial Skin Cleanser
65601-708-552024-10-01C16284748780-11030e365-6afd-111a-e063-dadaa90a10e2Antibacterial Skin Cleanser
65601-708-882024-10-01C16284748780-11030e365-6afd-111a-e063-dadaa90a10e2Antibacterial Skin Cleanser
65601-708-042024-07-30C16284748780-11030e365-6afd-111a-e063-dadaa90a10e2Antibacterial Skin Cleanser
65601-708-102024-07-30C16284748780-11030e365-6afd-111a-e063-dadaa90a10e2Antibacterial Skin Cleanser
65601-708-192024-07-30C16284748780-11030e365-6afd-111a-e063-dadaa90a10e2Antibacterial Skin Cleanser
65601-708-292024-07-30C16284748780-11030e365-6afd-111a-e063-dadaa90a10e2Antibacterial Skin Cleanser
65601-708-412024-07-30C16284748780-11030e365-6afd-111a-e063-dadaa90a10e2Antibacterial Skin Cleanser
65601-708-552024-07-30C16284748780-11030e365-6afd-111a-e063-dadaa90a10e2Antibacterial Skin Cleanser
65601-708-882024-07-30C16284748780-11030e365-6afd-111a-e063-dadaa90a10e2Antibacterial Skin Cleanser
65601-708-042024-01-30C16284748780-11030e365-6afd-111a-e063-dadaa90a10e2Antibacterial Skin Cleanser
65601-708-102024-01-30C16284748780-11030e365-6afd-111a-e063-dadaa90a10e2Antibacterial Skin Cleanser
65601-708-192024-01-30C16284748780-11030e365-6afd-111a-e063-dadaa90a10e2Antibacterial Skin Cleanser
65601-708-292024-01-30C16284748780-11030e365-6afd-111a-e063-dadaa90a10e2Antibacterial Skin Cleanser
65601-708-412024-01-30C16284748780-11030e365-6afd-111a-e063-dadaa90a10e2Antibacterial Skin Cleanser
65601-708-552024-01-30C16284748780-11030e365-6afd-111a-e063-dadaa90a10e2Antibacterial Skin Cleanser
65601-708-882024-01-30C16284748780-11030e365-6afd-111a-e063-dadaa90a10e2Antibacterial Skin Cleanser

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65601-70865601-708-04, 65601-708-19, 65601-708-41, 65601-708-55, 65601-708-10, 65601-708-29, 65601-708-88

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Source Document#

Source XML · Source PDF

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
37604bd3-e42c-34ed-e063-6394a90a7bfd3d85331a-de45-46c7-ab81-a5ca44415bb22025-06-12WarningsExact identifier
spl set id: 3d85331a-de45-46c7-ab81-a5ca44415bb2

Reported adverse events (FAERS/openFDA)#

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