Label: DYNA-HEX 2- chlorhexidine gluconate 2% solution
- NDC Code(s): 0116-1022-32
- Packager: Xttrium Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 14, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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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 or the patient 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
wounds which involve more than the superficial layers of the skin should not be routinely treated
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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 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
- Other information
- INACTIVE INGREDIENT
- Questions or comments?
- Laundering/Cleaning Instructions:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DYNA-HEX 2
chlorhexidine gluconate 2% solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0116-1022 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16) COCO DIETHANOLAMIDE (UNII: 92005F972D) ISOPROPYL ALCOHOL (UNII: ND2M416302) WATER (UNII: 059QF0KO0R) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0116-1022-32 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019422 12/14/2023 Labeler - Xttrium Laboratories, Inc. (007470579) Registrant - Xttrium Laboratories, Inc. (007470579) Establishment Name Address ID/FEI Business Operations Xttrium Laboratories, Inc. 007470579 manufacture(0116-1022)
