Active Ingredient
Chlorhexidine gluconate 4% solution
The following Structured Product Label (SPL) was submitted to the FDA by Xttrium Laboratories, Inc. for the product Antiseptic Skin Cleanser (NDC 0116-0401). 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 4% solution
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.
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.
use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
Surgical hand scrub
Healthcare personnel handwash:
Skin wound and general skin cleansing:
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
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 fo to www.P65Warnings.ca.gov
Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products. Rinse completely and use only non-chlorine detergents.
*This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.
NDC 36800-401-50
TopCare health
COMPARE TO HIBICLENS® ACTIVE INGREDIENT
DYE FREE
Antiseptic Skin Cleanser
(CHLORHEXIDINE CLUCONATE 4% SOLUTION)
ANTISEPTIC / ANTIMICROBIAL SKIN CLEANSER
FOR EXTERNAL USE ONLY
8 FL OZ (237 mL)
* Please review the disclaimer below.