Active Ingredient
Chlorhexidine gluconate 4% solution
The following Structured Product Label (SPL) was submitted to the FDA by Xttrium Laboratories, Inc. for the product Cliniclean (NDC 0116-0901). 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:
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
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.
NDC 69494-901-04
REF 90104
CliniClean
Chlorhexidine Gluconate 4%
Antispetic/Antimicrobial Solution
Non-Sterile
Patient Pre-Operative Prep, Surgical Hand Scrub, Healthcare Personnel Hand Wash. General Skin & Wound Cleanser
For Single-Use
Net Content: 4 fl oz (118mL)
DYE FREE
Manufactured for:
HR Pharmaceuticals, Inc.
York, PA 17402
cliniclean.com
Rev 4170-0 (02/2023)
4HRP04BTLLBL
NDC 69494-901-15
REF 901515
CliniClean
Chlorhexidine Gluconate 4%
Antispetic/Antimicrobial Solution
Non-Sterile
Patient Pre-Operative Prep, Surgical Hand Scrub, Healthcare Personnel Hand Wash. General Skin & Wound Cleanser
For Single-Use
Net Contents: 50 Single-Use 0.5 fl oz (15 mL) Packettes
DYE FREE
Manufactured for:
HR Pharmaceuticals, Inc.
York, PA 17402
cliniclean.com
Rev 4175-0 (02/2023)
4HRP15INNCTN
4HRP15PACKET
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