CHLORHEXIDINE GLUCONATE- chlorhexidine gluconate solution 
Rising Pharma Holdings, Inc.

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Drug Facts

Active ingredients

Chlorhexidine gluconate solution, 4%

Purposes

Surgical hand scrub

Healthcare personnel handwash

Skin wound and general skin cleanser

Uses

Warnings

For external use only

Allergy Alert

This product may cause a severe allergic reaction.

Symptoms may include:

  • wheezing/difficulty breathing
  • shock
  • facial swelling
  • hives
  • rash

If an allergic reaction occurs, stop use and seek medical help right away.

Do not use

  • if you are allergic to chlorhexidine gluconate or any other ingredients in this preparation
  • as a patient properative skin preparation (especially on the head or face)
  • in contact with 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 ear drums
  • if contact occurs, rinse with cold water right away
  • 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 underlying condition makes it necessary to reduce the bacterial population of the skin

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. 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 cleanser:

Other information

Inactive ingredients

cocamide DEA, cocamine oxide, fragrance, gluconic acid*, gluconolactone*, hydroxyethylcellulose, isopropyl alcohol 4%, PEG-75 lanolin, PEG-150 distearate, propylene glycol, quaternium-60, water *contains one or more of these ingredients

Questions or comments?

Call 1-884-874-7464 Monday through Friday 8:00 AM to 5:00 PM EST

WARNING: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov

Laundering/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.

Distributed by:

Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

Keep from freezing.

Issued: 07/2023

Chlorhexidine Gluconate Liquid Solution

NDC:16571-111-12; 118 mL in 1 BOTTLE

Chlhex-Glu-Sol-118ml-1

Chlhex-Glu-Sol-118ml-2

Chlhex-Glu-Sol-118ml-3

Chlorhexidine Gluconate Liquid Solution

NDC:16571-111-24; 236 mL in 1 BOTTLE

Chlhex-Glu-Sol-236ml-1

Chlhex-Glu-Sol-236ml-2

Chlhex-Glu-Sol-236ml-3

Chlorhexidine Gluconate Liquid Solution

NDC:16571-111-48; 473 mL in 1 BOTTLE

Chlhex-Glu-Sol-473ml

Chlorhexidine Gluconate Liquid Solution

NDC:16571-111-95; 946 mL in 1 BOTTLE

Chlhex-Glu-Sol-946ml

CHLORHEXIDINE GLUCONATE 
chlorhexidine gluconate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16571-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
COCAMINE OXIDE (UNII: QWA2IZI6FI)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
GLUCONIC ACID (UNII: R4R8J0Q44B)  
HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
QUATERNIUM-33 (UNII: XPS4174QZJ)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16571-111-12118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/2023
2NDC:16571-111-24237 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/2023
3NDC:16571-111-48473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/2023
4NDC:16571-111-95946 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01925807/26/2023
Labeler - Rising Pharma Holdings, Inc. (116880195)

Revised: 8/2023
Document Id: 99de08ac-7b69-4d09-829b-14d8f620986e
Set id: d53a01eb-7213-4f19-b74f-acbf0fd54418
Version: 1
Effective Time: 20230811
 
Rising Pharma Holdings, Inc.