Active Ingredients
Chlorhexidine gluconate solution, 4%
The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Chlorhexidine Gluconate (NDC 16571-111). 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 active ingredients, purposes, uses, warnings, allergy alert, do not use, when using this product, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Chlorhexidine gluconate solution, 4%
Surgical hand scrub
Healthcare personnel handwash
Skin wound and general skin cleanser
For external use only
This product may cause a severe allergic reaction.
Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
If swallowed, get medical help or contact a Poison Control Center right away.
Surgical hand scrub:
Healthcare personnel handwash:
Skin wound and general skin cleanser:
cocamide DEA, cocamine oxide, fragrance, gluconic acid*, gluconolactone*, hydroxyethylcellulose, isopropyl alcohol 4%, PEG-75 lanolin, PEG-150 distearate, propylene glycol, quaternium-60, water *contains one or more of these ingredients
Call 1-884-874-7464 Monday through Friday 8:00 AM to 5:00 PM EST
WARNING: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov
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.
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Keep from freezing.
Issued: 07/2023
* Please review the disclaimer below.