FDA.reportPublic FDA data

Indulgence/ProPower

Manufacturer
U S Chemical Corporation | Kutol Products Company
Effective date
2023-08-24
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
legacy-cache
Hydrated at
2026-08-01 21:26:53

Label at a glance#

ProductIndulgence/ProPower
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% w/w

OTC - PURPOSE SECTION

Antibacterial Agent

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on skin.

WARNINGS SECTION

For external use only.

Avoid contact with eyes. In case of contact, flush with plenty of water.

Stop use and ask a doctor if irritation or rash appears and persists.

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. ​EMERGENCY TELEPHONE: 1-866-923-4913

DOSAGE & ADMINISTRATION SECTION

To decrease bacteria on skin, apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

INACTIVE INGREDIENT SECTION

Water, cocamidopropyl betaine, cocamidopropyl PG-dimonium chloride phosphate, PEG-6 cocamide, laurtrimonium chloride, aloe barbadensis leaf juice, tocopheryl acetate (vitamin E), fragrance, iodopropynyl butylcarbamate, methylisothiazolinone, yellow 5, red 33.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61307-213-102022-01-31C16284748780-19d75b9d0-f523-f424-e053-dadaa90a57ceUS Chem F213F
61307-213-412022-01-31C16284748780-19d75b9d0-f523-f424-e053-dadaa90a57ceUS Chem F213F
61307-213-102022-01-28C16284748780-19d75b9d0-f523-f424-e053-dadaa90a57ceUS Chem F213F
61307-213-412022-01-28C16284748780-19d75b9d0-f523-f424-e053-dadaa90a57ceUS Chem F213F
61307-213-412020-03-24C16284748780-19d75b9d0-f523-f424-e053-dadaa90a57ceUS Chem F213F
61307-213-412020-01-31C16284748780-19d75b9d0-f523-f424-e053-dadaa90a57ceUS Chem F213F

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61307-21361307-213-41, 61307-213-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
PEG-6 COCAMIDEYZ6NLA4O1EIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
D&C RED NO. 339DBA0SBB0LIACT
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
03a8d733-d4d1-c48f-e063-6294a90a862147556b9b-cd84-6385-e054-00144ff8d46c2023-08-24WarningsExact identifier
spl id: 03a8d733-d4d1-c48f-e063-6294a90a8621
spl set id: 47556b9b-cd84-6385-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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