FDA.reportPublic FDA data

Ultra Mild Antibacterial Skin Cleanser

Manufacturer
Betco Corporation, Ltd.
Effective date
2019-04-09
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-02 00:26:27

Label at a glance#

ProductUltra Mild Antibacterial Skin Cleanser
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

​Active Ingredient

​Benzalkonium Chloride 0.13%

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

  • 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 Posion Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • ​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 INGREDIENT SECTION

Inactive Ingredients

​Water, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Propylene Glycol, Sodium Chloride, Glycerin, PEG-4 Rapeseedamide, Dimethicone PEG-7 Cocoate, Ethanol, Fragrance, Bronopol, Diisoporpanolamine, Magnesium Nitrate, FD&C Yellow #5, Methychloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, FD&C Red #40.

OTC - QUESTIONS SECTION

888-GO-BETCO (888-462-3826)

Betco.com

OTC - PURPOSE SECTION

Purpose

Antibacterial

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Ultra Mild Antibacterial Lotion Skin Cleanser

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

jpgjpg74404-00 Ultra Mild Antibacterial.jpg74404-00 Ultra Mild Antibacterial.jpg

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65601-71065601-710-10, 65601-710-04, 65601-710-41, 65601-710-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CHLORIDE451W47IQ8XIACT
GLYCERINPDC6A3C0OXIACT
PEG-4 RAPESEEDAMIDE89575CN928IACT
DIMETHICONE92RU3N3Y1OIACT
COCONUT ACID40U37V505DIACT
ALCOHOL3K9958V90MIACT
BRONOPOL6PU1E16C9WIACT
DIISOPROPANOLAMINE0W44HYL8T5IACT
MAGNESIUM NITRATE77CBG3UN78IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C RED NO. 40WZB9127XOAIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
aa80b9f4-8a5f-3e14-e053-2a95a90a8aaba3e6166c-e5e1-4e6b-92ee-5a7518b29e562020-07-15WarningsExact identifier
spl set id: a3e6166c-e5e1-4e6b-92ee-5a7518b29e56

Reported adverse events (FAERS/openFDA)#

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