DYNA-HEX 4
DYNA-HEX 4 is an FDA drug label for the active ingredient CHLORHEXIDINE GLUCONATE manufactured by Xttrium Laboratories, Inc. administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231109.
- Generic name
- CHLORHEXIDINE GLUCONATE
- Manufacturer
- Xttrium Laboratories, Inc.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 0116-1060
- Application
- NDA019125
- Label effective
- 20231109
Active ingredients
Indications & Usage
Uses surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: helps reduce bacteria that potentially can cause disease skin wound and general skin cleansing
Dosage & Administration
Directions use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. Surgical hand scrub: wet hands and forearms with water scrub for 3 minutes with 3 full pumps (5 grams) of product and a wet brush paying close attention to the nails, cuticles, and interdigital spaces a seperate nail cleaner may be used rinse thoroughly wash for an additional 3 minutes with 3 full pumps (5 grams) of product and rinse under running water dry thoroughly Healthcare personnel handwash: wet hands with water dispense 3 full pumps (5 grams) of product into cupped hands and wash in a vigorous manner for 15 seconds rinse and dry thoroughly Skin wound and general skin cleansing: thoroughly rinse the area to be cleaned with water apply the minimum amount of product necessary to cover the skin or wound area and wash gently rinse again thoroughly
Contraindications
Not available.
Warnings
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 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 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.
Adverse Reactions
Not available.