Antimicrobial cleansing gel

Manufacturer
A-Cute Derm, Incorporated | Bio-Medical & Pharmaceutical Manufacturing Corporation
Effective date
2021-04-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:40:05

Label at a glance#

ProductAntimicrobial cleansing gel
Active ingredientBENZETHONIUM CHLORIDE
Label structure10 sections

Indications and uses

B-KLEER™ is a unique, non-drying cleanser. •Designed for all skin types and pH balanced. •Excellent for postoperative care. •May be used as a topical antimicrobial to help protect against skin infection.

Dosage and administration

•Wet hands and other areas to be treated. •Place a small amount of gel in your hands and work into lather. •Apply lather to areas to be treated using a gentle, circular motion. •Rinse clean.

Label contents#

Full prescribing information#

DRUG FACTS

STATEMENT OF IDENTITY SECTION

Antimicrobial

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzethonium Chloride (0.2%)

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

B-KLEER™ is a unique, non-drying cleanser. •Designed for all skin types and pH balanced. •Excellent for postoperative care. •May be used as a topical antimicrobial to help protect against skin infection.

Warnings

WARNINGS SECTION

For external use only.
Do not use in eyes.
Ask a doctor before use if you have deep wounds or puncture wounds.
Stop use and ask a doctor if irritation develops.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

•Wet hands and other areas to be treated. •Place a small amount of gel in your hands and work into lather. •Apply lather to areas to be treated using a gentle, circular motion. •Rinse clean.

Other Information

OTHER SAFETY INFORMATION

•Alcohol Free •Moisturizes •Made in USA

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Ammonium Lauryl Sulfate, Lauramidopropyl Betaine, Hydroxypropyl Bis-Hydroxyethyl-dimonium Chloride, Propylene Glycol, Hydroxypropylmethylcellulose, Sodium Chloride, Diazolidinyl Urea, PEG-4 Laurate, Methylparaben, Propylparaben, 3-iodo-2-propynylbutylcarbamate.

Questions or Comments

OTC - QUESTIONS SECTION

A-Cute Derm, Inc.

1810 Cravens Road

Stafford, TX 77477

800.922.2883

M-F 8:30am-5:30pm

info@a-cutederm.com

www.a-cutederm.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

antimicrobial antimicrobialantimicrobial

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61619-104-01Antimicrobial cleansing gel29.57 mL in 1 BOTTLE, PLASTICLOTION29.575
61619-104-04Antimicrobial cleansing gel118.29 mL in 1 BOTTLE, PLASTICLOTION118.295
61619-104-08Antimicrobial cleansing gel236.59 mL in 1 BOTTLE, PLASTICLOTION236.595
61619-104-09Antimicrobial cleansing gel1 in 1 BOXLOTION15
61619-104-32Antimicrobial cleansing gel946.35 mL in 1 BOTTLE, PLASTICLOTION946.355

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61619-104ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) LOTION [A-CUTE DERM, INCORPORATED]5Legacy NDC, 5 package rows20210430_9eefba02-85ae-c966-e053-2995a90a27a3.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61619-10461619-104-04, 61619-104-32, 61619-104-01, 61619-104-09, 61619-104-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
c1200e4e-c4f3-9067-e053-2a95a90af5099eefba02-85ae-c966-e053-2995a90a27a32021-04-29WarningsExact identifier
spl id: c1200e4e-c4f3-9067-e053-2a95a90af509
spl set id: 9eefba02-85ae-c966-e053-2995a90a27a3

Reported adverse events (FAERS/openFDA)#

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