Active Ingredient
Chlorhexidine gluconate 2% solution
The following Structured Product Label (SPL) was submitted to the FDA by Xttrium Laboratories, Inc. for the product Dyna-hex 2 (NDC 0116-1022). 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, uses, 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.
Chlorhexidine gluconate 2% solution
Antiseptic
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.
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
wounds which involve more than the superficial layers of the skin should not be routinely treated
irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
if swallowed, get medical help or contact a Poison Control Center right away.
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 5 mL of solution (4 full strokes) and a wet brush, paying close attention to the nails, cuticles and interdigital spaces
a separate nail cleaner may be used
rinse thoroughly
wash for an additional 3 minutes with 5 mL of solution (4 full strokes) and rinse under running water
dry thoroughly
Healthcare personnel handwash:
wet hands with water
dispense 5 mL of solution (4 full strokes) into cupped hands and wash in a vigorous manner for 15 seconds
rinse and dry thoroughly
store at 20-25°C (68-77°F)
avoid excessive heat above 40°C (104°F)
citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water
Questions or comments?
call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST
Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach. Rinse completely and use only non-chlorine detergents.
NDC 0116-1022-32
DYNA-HEX 2®
Chlorhexidine Gluconate 2% Solution Antiseptic
Contains: 2% Chlorhexidine Gluconate
Distributed By: Xttrium Laboratories, Inc. Mount Prospect, IL 60056
CHLORHEXIDINE GLUCONATE
Net Contents: 32 fl oz (1 qt) (946 mL)
2DYN32SQLBL
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