Drug Facts
Kills 99.9% of harmful germs in 30 seconds.
Antimicrobial Cleansing Gel
FDA Label NDC 61619-104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by A-cute Derm, Incorporated for the product Antimicrobial Cleansing Gel (NDC 61619-104). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients, inactive ingredients, purpose, uses, warnings, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Benzethonium Chloride (0.2%)
Inactive Ingredients
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.
Purpose
Antimicrobial Wash
Uses
•B-KLEER™ is a unique, non-drying cleanser. •Use on all skin types. •pH balanced. •May be used as a topical antimicrobial to help protect against skin infection.
Warnings
•External use only. •Do not use in eyes. •In case of deep wounds or puncture wounds, consult a physician. •If irritation develops and persists for more than a few days, discontinue use and consult a physician.
Directions
•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
•Alcohol Free •Moisturizes •Made in USA
Questions Or Comments
A-Cute Derm, Inc.
1810 Cravens Road
Stafford, TX 77477
800.922.2883
M-F 8:30am-5:30pm
www.a-cutederm.com
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