CHLORHEXIDINE GLUCONATE SOLUTION 0.75% ANTISEPTIC- chlorhexidine gluconate solution 0.75% antiseptic solution 
Bajaj Medical, LLC

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Drug Facts

Active ingredient

Chlorhexidine gluconate solution, 0.75%

Purpose

Antiseptic

Use

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 are allergic to chlorhexidine gluconate or any other ingredient in this product

When using this product

  • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated eardrums.
  • if solution should contact these areas, rinse out promptly and thoroughly with water
  • do not use routinely if you have wounds which involve more than the superficial layers of the skin

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

Healthcare personnel handwash:

  • wet hands with water
  • dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 30 seconds
  • rinse and dry thoroughly

Other information

Inactive ingredients

citric acid, cocamide DEA, FD&C yellow #5, FD&C red #4, fragrance, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water, ricinoleamidopropyl trimethyl ammonium chloride

Questions or comments?

call 1-800-581-2528, 24 hours a day, 7 days a week

Package/Label Principal Display Panel

Chlorhexidine Gluconate Solution

0.75%

ANTISEPTIC

FOR EXTERNAL USE ONLY

Bajaj Medical

Chicago IL 60609

4 fl oz (118 mL)

NDC 61037-414-01

MADE IN THE USA

FDA APPROVED

4ozlbl

Chlorhexidine Gluconate Solution

0.75%

ANTISEPTIC

FOR EXTERNAL USE ONLY

Bajaj Medical

Chicago IL 60609

8 fl oz (236 mL)

NDC 61037-414-02

MADE IN THE USA

FDA APPROVED

8ozlbl

Chlorhexidine Gluconate Solution

0.75%

ANTISEPTIC

FOR EXTERNAL USE ONLY

Bajaj Medical

Chicago IL 60609

16 fl oz (473 mL)

NDC 61037-414-05

MADE IN THE USA

FDA APPROVED

16ozlbl

Chlorhexidine Gluconate Solution

0.75%

ANTISEPTIC

FOR EXTERNAL USE ONLY

Bajaj Medical

Chicago IL 60609

32 fl oz (946 mL)

NDC 61037-414-06

MADE IN THE USA

FDA APPROVED

32ozlbl

Chlorhexidine Gluconate Solution

0.75%

ANTISEPTIC

FOR EXTERNAL USE ONLY

Bajaj Medical

Chicago IL 60609

128 fl oz (3785 mL)

NDC 61037-414-07

MADE IN THE USA

FDA APPROVED

128ozlbl

Chlorhexidine Gluconate Solution

0.75%

ANTISEPTIC

FOR EXTERNAL USE ONLY

Bajaj Medical

Chicago IL 60609

8 fl oz (236 mL)

NDC 61037-414-03

MADE IN THE USA

FDA APPROVED

8ozlblclr

Chlorhexidine Gluconate Solution

0.75%

ANTISEPTIC

FOR EXTERNAL USE ONLY

Bajaj Medical

Chicago IL 60609

8 fl oz (236 mL)

NDC 61037-414-04

MADE IN THE USA

FDA APPROVED

8ozlblwht

Chlorhexidine Gluconate Solution

0.75%

ANTISEPTIC

FOR EXTERNAL USE ONLY

Bajaj Medical

Chicago IL 60609

40.6 fl oz (1.2 L)

NDC 61037-414-08

MADE IN THE USA

FDA APPROVED

1200mllbl

Keep from freezing.

CHLORHEXIDINE GLUCONATE SOLUTION 0.75% ANTISEPTIC 
chlorhexidine gluconate solution 0.75% antiseptic solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61037-414
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE0.75 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
RICINOLEAMIDOPROPYLTRIMONIUM CHLORIDE (UNII: 93OU7D1C3U)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61037-414-01118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/2014
2NDC:61037-414-02236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/2014
3NDC:61037-414-05473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/2014
4NDC:61037-414-06946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/2014
5NDC:61037-414-073785 mL in 1 JUG; Type 0: Not a Combination Product09/30/2014
6NDC:61037-414-03236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/12/2017
7NDC:61037-414-04236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/12/2017
8NDC:61037-414-081200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/12/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02011109/30/2014
Labeler - Bajaj Medical, LLC (078774921)
Registrant - Bajaj Medical, LLC (078774921)
Establishment
NameAddressID/FEIBusiness Operations
Bajaj Medical, LLC078774921label(61037-414) , analysis(61037-414) , manufacture(61037-414) , pack(61037-414)

Revised: 12/2022
Document Id: f0b7b337-be39-2e5f-e053-2995a90a3c8c
Set id: 014a5f36-0396-498b-901f-9a86df4e11fe
Version: 15
Effective Time: 20221226
 
Bajaj Medical, LLC