CLINICLEAN- chlorhexidine gluconate 4% solution 
Xttrium Laboratories, Inc.

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4% HR Pharma 4-oz Foamer

Active ingredient

Chlorhexidine gluconate 4% solution

Purpose

Antiseptic

Uses

surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

healthcare personnel handwash: helps reduce bacteria that potentially can cause disease

skin wound and general skin cleansing

Warnings

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.

Do not use

When using this product

Stop use and ask a doctor if

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Surgical hand scrub:

Healthcare personnel handwash:

Skin wound and general skin cleansing:

Other information

Inactive ingredients

cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

Questions or comments?

call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST

Laudering/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.

Package Label

NDC 69464-901-05

REF 90604

CliniClean

Chlrohexidine Gluconate 4%

Antiseptic/Antimicrobial Solution with Foaming Pump

Surgical Hand Scrub, Heath Personnel Hand Wash, General Skin & Wound Cleanser

Net Content: 4fl oz (118 mL)

DYE FREE

Manufactured for:

HR Pharmaceuticals, Inc.

York, PA 17402

cliniclean.com

Rev 4176 Rev 2

(12/2023)

4HRP04FMBTLLBLA

HRP 4oz FM single

CLINICLEAN 
chlorhexidine gluconate 4% solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-0901
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PEG-75 LANOLIN (UNII: 09179OX7TB)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
WATER (UNII: 059QF0KO0R)  
TRIDECYL ALCOHOL (UNII: 8I9428H868)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0116-0901-05118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/15/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912503/15/2023
Labeler - Xttrium Laboratories, Inc. (007470579)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories, Inc007470579manufacture(0116-0901)

Revised: 12/2023
Document Id: 0cdebd32-e88e-b4dd-e063-6394a90a8748
Set id: f8346bd2-72af-e396-e053-6294a90ab602
Version: 2
Effective Time: 20231219
 
Xttrium Laboratories, Inc.