Active Ingredient
Chlorhexidine gluconate solution, 0.75%
Chlorhexidine Gluconate Solution 0.75% Antiseptic
FDA Label NDC 81657-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Usa Medical Supply Llc for the product Chlorhexidine Gluconate Solution 0.75% Antiseptic (NDC 81657-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Use
- healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
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 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
- 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
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
Dr. Dean
Chlorhexidine Gluconate
Solution
0.75%
Up to 6 Hour Protection
Antimicrobial Skin Soap
FOR EXTERNAL USE ONLY
Distributed by USA Medical Supply
Northbrook, IL 60062
www.usamedicalsupply.com
4 fl oz (118 mL)
NDC 81657-001-01
MADE IN THE USA
FDA APPROVED
California Prop 65 WARNING
Keep from freezing.
Fourwht (Chg75wht4oz.jpg)
Dr. Dean
Chlorhexidine Gluconate
Solution
0.75%
Up to 6 Hour Protection
Antimicrobial Skin Soap
FOR EXTERNAL USE ONLY
Distributed by USA Medical Supply
Northbrook, IL 60062
www.usamedicalsupply.com
8 fl oz (236 mL)
NDC 81657-001-02
MADE IN THE USA
FDA APPROVED
California Prop 65 WARNING
Keep from freezing.
Eightwht (Chg75wht8oz.jpg)
Dr. Dean
Chlorhexidine Gluconate
Solution
0.75%
Up to 6 Hour Protection
Antimicrobial Skin Soap
FOR EXTERNAL USE ONLY
Distributed by USA Medical Supply
Northbrook, IL 60062
www.usamedicalsupply.com
8 fl oz (236 mL)
NDC 81657-001-04
MADE IN THE USA
FDA APPROVED
California Prop 65 WARNING
Keep from freezing.
Eightovl (Chg75ovl8oz.jpg)
Dr. Dean
Chlorhexidine Gluconate
Solution
0.75%
Up to 6 Hour Protection
Antimicrobial Skin Soap
FOR EXTERNAL USE ONLY
Distributed by USA Medical Supply
Northbrook, IL 60062
www.usamedicalsupply.com
128 fl oz (3785 mL)
NDC 81657-001-03
MADE IN THE USA
FDA APPROVED
California Prop 65 WARNING
Keep from freezing.
Galwht (Chg75wht128oz.jpg)
Other Safety Information
Keep from freezing.
Calstat (Calstat.jpg)
* Please review the disclaimer below.
