Drug Facts

Drug Facts
SPL v15
SPL
SPL Set ID 014a5f36-0396-498b-901f-9a86df4e11fe
Route
TOPICAL
Published
Effective Date 2014-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (0.75 mg)
Inactive Ingredients
Coco Diethanolamide Hydroxyethyl Cellulose (140 Cps At 5%) Isopropyl Alcohol Lauramine Oxide Ricinoleamidopropyltrimonium Chloride Water Citric Acid Monohydrate Fd&c Yellow No. 5 Fd&c Red No. 4

Identifiers & Packaging

Marketing Status
NDA Active Since 2014-09-30
Description

Chlorhexidine gluconate solution, 0.75%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Chlorhexidine gluconate solution, 0.75%

Use
  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
Section 44425-7

Keep from freezing.

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.

Directions
  • use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns.
Do Not Use
  • if you are allergic to chlorhexidine gluconate or any other ingredient in this product
Active Ingredient

Chlorhexidine gluconate solution, 0.75%

Other Information
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
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

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.

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
Keep Out of Reach of Children.

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

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

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

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

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

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

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

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

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

Structured Label Content

Use
  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
Section 44425-7 (44425-7)

Keep from freezing.

Purpose

Antiseptic

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.

Directions
  • use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns.
Do Not Use (Do not use)
  • if you are allergic to chlorhexidine gluconate or any other ingredient in this product
Active Ingredient (Active ingredient)

Chlorhexidine gluconate solution, 0.75%

Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
Inactive Ingredients (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? (Questions or comments?)

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

When Using 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 (Stop use and ask a doctor if)

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

Healthcare Personnel Handwash: (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
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Package/label Principal Display Panel (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

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

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

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

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

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

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

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

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:26.975025 · Updated: 2026-03-14T23:00:52.351984