Otc - Active Ingredient
Active ingredient
Chlorhexidine gluconate solution, 4%
The following Structured Product Label (SPL) was submitted to the FDA by Henry Schein, Inc. for the product Maxiclens Chlorhexidine Gluconate Liquid Solution, 4% (NDC 0404-0221). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient
Chlorhexidine gluconate solution, 4%
Purposes
Surgical hand scrub
Healthcare personnel handwash
Skin wound and general skin cleanser
Uses
surgical hand scrub:significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
healthcare personnel handwash:handwash to help reduce bacteria that potentially can cause disease
skin wound and general skin cleanser:helps reduce bacteria on the skin
Warnings
For external use only
Allergy alert
This product may cause a severe allergic reaction.
Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
Do not use
When using this product
Stop use and ask a doctor ifirritation, sensitization or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Surgical hand scrub:
Healthcare personnel handwash:
Skin wound and general skin cleanser:
Other information
Inactive ingredients
cocamide DEA, cocamine oxide, fragrance, gluconic acid*, gluconolactone*, hydroxyethyl cellulose, isopropyl alcohol 4%, PEG-75 lanolin, PEG-150 distearate, propylene glycol, quaternium-60, water
*contains one or more of these ingredients
Questions or comments?
Call 1-800-472-4346 Monday through Friday 8:00 AM to 5:00 PM EST
NDC 0404-0221-04
Maxiclens TM
Antiseptic Skin Cleanser
(Chlorhexidine Gluconate 4%)
NON-STERILE
FOR EXTERNAL USE ONLY
Distributed By
HENRY SCHEIN INC.
135 Duryea Road
Melville, NY 11747 USA
Net Contents: 16 fl oz (473 mL)
Made in U.S.A.
Laundering/Cleaning Instructions:Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach. Rinse completely and use only non-chlorine detergents.
Keep from freezing.
* Please review the disclaimer below.