Active Ingredient
Chlorhexidine gluconate 4% solution
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Antiseptic Skin Cleanser (NDC 70000-0407). 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.
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
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.
*This product is not manufactured or districuted by Regent Medical Limited (United Kingdom Corp.), owner of the registered trademark Hibiclens ®.
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 P65Warnings.ca.gov
NDC 70000-0407-1
Leader
Antisptic Skin Cleanser
Chlorhexidine Gluconate 4% Solution
Antiseptic/Antimicrobial Skin Cleanser
For External Use Only
8 fl (237 mL)
* Please review the disclaimer below.