Foaming Antiseptic

Manufacturer
State Industrial Products | Kutol Products Company
Effective date
2023-08-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:26:55

Label at a glance#

ProductFoaming Antiseptic
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Directions: To decrease bacteria on skin, apply a small amount covering hands with product for 30 seconds. Add water, lather and rinse. This product should be used once or twice daily as part of the daily cleaning routine. Children under 6 years of age should be supervised when using this product.

INDICATIONS & USAGE SECTION

Uses: Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Benzalkonium Chloride 0.13% w/w

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.

OTC - PURPOSE SECTION

Purpose Antibacterial Agent

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Cocamidopropyl PG-Dimonium Chloride Phosphate, Cocamidopropyl Betaine, PEG-6 Cocamide, Laurtrimonium Chloride, Iodopropynyl Butylcarbamate, Methylisothiazolinone.

WARNINGS SECTION

Warnings: For external use only. Contact with eyes should be avoided. In case of contact, immediately flush with water. Stop use and ask a doctor if irritation or rash appears and last more that 72 hours.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

State LabelState LabelPrincipal Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64542-683-412022-01-31C16284748780-1d6a99b39-ee73-a426-e053-dadaa90af4c2State Industrial F683
64542-683-412022-01-28C16284748780-1d6a99b39-ee73-a426-e053-dadaa90af4c2State Industrial F683

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64542-68364542-683-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
03a8bd37-d221-2a2d-e063-6294a90a0406a07155c1-d120-5050-e053-2995a90a84d22023-08-24WarningsExact identifier
spl id: 03a8bd37-d221-2a2d-e063-6294a90a0406
spl set id: a07155c1-d120-5050-e053-2995a90a84d2

Reported adverse events (FAERS/openFDA)#

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