Drug Facts
Kills 99.9% of harmful germs in 30 seconds.
Antisepation
FDA Label NDC 61619-717
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 Antisepation (NDC 61619-717). 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, purpose, uses, warnings, directions, inactive ingredients, 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%)
Purpose
Antimicrobial
Uses
•AntisepationTM 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
•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.
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.
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
Principal Display Panel
ANTISEPATIONTM
CLEANSING GEL
Kills 99.9% of Harmful
Germs In 30 Seconds
NDC# 61619-717-14
4.0 FL OZ (118.3 ml
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