CLINICLEAN- chlorhexidine gluconate 4% solution 
HR Pharmaceuticals, Inc.

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4% HR Pharma 15 mL Packets, 15mL Carton, 4oz Flip Top

Active ingredient

Chlorhexidine gluconate 4% solution

Purpose

Antiseptic

Uses

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

  • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
  • in contact with the meninges
  • in the genital area

When using this product

  • keep out of eyes, ears and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardurms.
  • if solution should contact these areas, rinse out promptly and thoroughly with water
  • 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 advised by a healthcare provider

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:

Patient preoperative skin preparation:

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.

Display Panels

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

HRP 4oz FT 1

HRP 4oz FT 2

HRP 4oz FT 3

HRP 4oz FT 4

HRP 4oz FT 5

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

HRP 15ml Cart 1

HRP 15ml Cart 2

HRP 15ml Cart 3

HRP 15ml Cart 4

HRP 15ml Cart 5

4HRP15PACKET

HRP 15ml pkt 1

HRP 15ml pkt 2

CLINICLEAN 
chlorhexidine gluconate 4% solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69464-901
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:69464-901-1550 in 1 CARTON03/23/2023
115 mL in 1 PACKET; Type 0: Not a Combination Product
2NDC:69464-901-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/23/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912503/23/2023
Labeler - HR Pharmaceuticals, Inc. (117164328)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories, Inc007470579manufacture(69464-901)

Revised: 3/2023
Document Id: f7984bbf-bc63-ea71-e053-6394a90add2c
Set id: f7984baf-99e8-94a2-e053-6294a90ac22d
Version: 1
Effective Time: 20230323
 
HR Pharmaceuticals, Inc.