Active Ingredient
Chlorhexidine Gluconate 4% Solution
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Antiseptic Skin Cleanser (NDC 36800-401). 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
wounds which involve more than the superficial layers of the skin should not be routinely treated
repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population of the skin
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:
Patient preoperative skin preparation:
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 contains a chemical (cocamide DEA) known to the State of California to cause cancer.
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®
Antiseptic Skin Cleanser
(Chlorhexidine Gluconate 4% solution)
Antiseptic/Antimicrobial Skin Cleanser
FOR EXTERNAL USE ONLY
DYE FREE
Compare to the active ingredient in Hibiclens®*
8FL OZ. (237 mL)
* Please review the disclaimer below.