1. Home
  2. Labeler Index
  3. Bajaj Medical, Llc
  4. 61037-414
  5. Label Information: Chlorhexidine Gluconate Solution 0.75% Antiseptic

FDA Label for Chlorhexidine Gluconate Solution 0.75% Antiseptic

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN
    9. OTHER SAFETY INFORMATION
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OF COMMENTS?
    14. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Chlorhexidine Gluconate Solution 0.75% Antiseptic Product Label

The following document was submitted to the FDA by the labeler of this product Bajaj Medical, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



chlorhexidine gluconate 0.75% solution


Purposes



Antispetic


Uses



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

Warnings



For external use only.


Do Not Use



  • if you are allergic to chlorhexidine gluconate or any other ingredients
  • in contact with meninges
  • in the genital area
  • as a preoperative skin preparation (especially on the head and face)
  • on skin wonds
  • general skin cleanser as surgical hand scrub

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 eardrums.
  • if solution should contact these areas, rinse out promptly and thoroughly with water

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.


Other Safety Information



This product contains a chemical known to the State of California to cause Cancer.


Directions



  • use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns.

    • 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



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

Inactive Ingredients



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


Questions Of Comments?



Call 1-855-332-2525 Monday through Friday7:00 AM to 3:30 PM


Package/Label Principal Display Panel



NDC 61037-413-01

DYNA-HEX 75

Antiseptic Handwash

Chlorhexidine Gluconate 0.75% Solution

FDA Approved Antiseptic Handwash

Contains: 0.75% Chlorhexidine Gluconate

Distributed by: Bajaj Medical, LLC

415 W. Pershing Rd.,

Chicago, IL 60609

FOR EXTERNAL USE ONLY

Net Contents: 4 fl oz (118 ml)


* Please review the disclaimer below.