Label: DYNA-HEX 2- chlorhexidine gluconate liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 67659-901-98 - Packager: Team Technologies, Inc
- This is a repackaged label.
- Source NDC Code(s): 0116-1021
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 24, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Purposes
-
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 general cleansing
-
Warnings
For external use only
Do not use
- if you are allergic to chlorhexidine gluconate or any other ingredients
- in contact with meninges
- in the genital area
- as a preoperative skin preparation of the head or face
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
- wound which involve more than the superficial layers of skin should not be routinely treated
- repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population of the skin
-
Direction
- use with care in premature infants and 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 throughly 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 minutes
- dry with sterile towel
- repeat procedure for an additional 2 minutes and dry with sterile towel
Patient preoperative skin preparation:
- apply product liberally to surgical site and swab for at least 2 minutes
- dry with sterile towel
- repeat procecedure for an additional 2 minutes and dry with sterile towel
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
- other information
- Inactive ingredients
- Questions or comments?
- Package Label
-
INGREDIENTS AND APPEARANCE
DYNA-HEX 2
chlorhexidine gluconate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67659-901(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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCO DIETHANOLAMIDE (UNII: 92005F972D) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) ISOPROPYL ALCOHOL (UNII: ND2M416302) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67659-901-98 118 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package 08/24/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019422 01/01/2014 Labeler - Team Technologies, Inc (192339703) Registrant - Team Technologies, Inc (192339703) Establishment Name Address ID/FEI Business Operations Team Technologies, Inc 079527756 repack(67659-901) , relabel(67659-901)
