- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
-
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
- patient preoperative skin preparation: preparation of the patient's skin prior to surgery
- skin wound and skin cleansing
- Warnings
- Do not use
-
When using this product
- keep out of eyes, ears, and mouth. May cause serious and permenent 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
- wounds which involve more than the superficial layers of the skin should not be routinely treated
- repeated general skin cleansing of large body areas should not be done except when advised by a health care provider
- Stop use and ask a doctor if
- Keep out of reach of children
-
Directions
- use with care in premature infants under 2 months of age. These products may cause irritation or chemical burns.
Surgical hand scrub:
- wet hands and forearms under running water for 30 seconds. Clean fingernails using a nailstick or similar cleaner.
- scrub for 1.5 minutes with about 8 mL of product with or without a wet brush paying close attention to the nails, cuticles and skin between the fingers
- rinse thoroughly under running water for 30 seconds
- wash for an additional 1.5 minutes with 8 mL of product and rinse under running water for 30 seconds
- dry thoroughly
Healthcare personnel handwash:
- wet hands with water
- dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 15 seconds
- rinse and dry thoroughly
Patient preoperative skin preparation:
- apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel
- repeat procedurefor an additional 2 minuted and dry with a sterile towel
Skin wound and general skin cleaning:
- thoroughly rinse the area to be cleaned with water
- appl the minimum amount of product necessary to cover the skin or wound area and wash gently
- rinse again thoroughly
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DYNA-HEX 2
chlorhexidine gluconate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0116-1021 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16) ISOPROPYL ALCOHOL (UNII: ND2M416302) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCO DIETHANOLAMIDE (UNII: 92005F972D) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0116-1021-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019422 01/01/2014 Labeler - Xttrium Laboratories, Inc. (007470579) Registrant - Xttrium Laboratories, Inc. (007470579) Establishment Name Address ID/FEI Business Operations Xttrium Laboratories, Inc. 007470579 manufacture(0116-1021)