Otc - Active Ingredient
Chlorhexidine gluconate 4% Solution
The following Structured Product Label (SPL) was submitted to the FDA by Hr Pharmaceuticals, Inc. for the product Cliniclean (NDC 69464-901). 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 otc - active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, 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.
if 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
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 69464-901-08
REF 90208
CliniClean
Chlorhexidine Gluconate 4%
Antiseptic/Antimicrobial Solution
Surgical Hand Scrub, Healthcare Personnel Hand Wash, General Skin & Wound Cleanser
Net Contents: 8 fl oz (237 mL)
DYE FREE
Manufactured for:
HR Pharmaceutials, Inc.
York, PA 17402
cliniclean.com
4171 Rev 1
(10/2023)
4HRP08BTLLBLA
NDC 69464-901-16
REF 90316
CliniClean
Chlorhexidine Gluconate 4%
Antiseptic/Antimicrobial Solution
Surgical Hand Scrub, Healthcare Personnel Hand Wash, General Skin & Wound Cleanser
Net Contents: 16 fl oz (473 mL)
DYE FREE
Manufactured for:
HR Pharmaceutials, Inc.
York, PA 17402
cliniclean.com
4172 Rev 1
(10/2023)
4HRP16BTLLBLA
NDC 69464-901-32
REF 90432
CliniClean
Chlorhexidine Gluconate 4%
Antiseptic/Antimicrobial Solution
Surgical Hand Scrub, Healthcare Personnel Hand Wash, General Skin & Wound Cleanser
Net Contents: 32 fl oz (946 mL)
DYE FREE
Manufactured for:
HR Pharmaceutials, Inc.
York, PA 17402
cliniclean.com
Rev 4171-0 (02/2023)
4HRP32BTLLBL
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