Active Ingredient
Chlorhexidine gluconate
The following Structured Product Label (SPL) was submitted to the FDA by Xttrium Laboratories, Inc. for the product Antiseptic Skin Cleanser (NDC 0116-1061). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Chlorhexidine gluconate
Antiseptic
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.
if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
in contact with meninges
in the genital area
as a preoperative skin preparation of the head or face (only in 4-oz)
irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
If swallowed, get medical help or contact a Poison Control Center right away.
Surgical hand scrub:
Healthcare personnel handwash:
Patient preoperative skin preparation: (only on 4-oz)
Skin wound and general skin cleaning:
cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol
call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST
NDC 0116-1061-04
DYNA-HEX 4 ®
(Chlorhexidine Gluconate 4% Solution)
Antiseptic
Contains: 4% Chlorhexidine Gluconate
Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056
FOR EXTERNAL USE ONLY
Net Contents: 4 fl oz (118 mL)
NDC 0116-1061-08
DYNA-HEX 4 ®
(Chlorhexidine Gluconate 4% Solution)
Antiseptic
Contains: 4% Chlorhexidine Gluconate
Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056
FOR EXTERNAL USE ONLY
Net Contents: 8 fl oz (237 mL)
* Please review the disclaimer below.