DYNA-HEX 2- chlorhexidine gluconate liquid

Dyna-Hex by

Drug Labeling and Warnings

Dyna-Hex by is a Otc medication manufactured, distributed, or labeled by Team Technologies, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

 Chlorhexidine gluconate 2% Solution

Purposes

surgical hand scrub
healthcare personnel handwash
patient operative skin preparation
skin wound and general skin cleansing

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

Stop use and ask a doctor

if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious conditions.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

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

• store at 20-25 C (68-77 F)
• avoid excessive heat above 40 C (104 F)
  

Inactive ingredients

citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

Questions or comments?

 Call 1-800-587-3271 Monday through Friday 8:00 AM to 4:30 PM

Package Label

NDC: 0116-1021-04

DYNA-HEX 2 ®

(Chlorhexidine Gluconate 2% Solution)

Antispeptic

Contains:  2% Chlorhexidine Gluconate

Distributed By: Xttrium Laboratories, Inc., Mount Prospect, IL 60056

For External Use Only.

Net Contents: 4 fl OZ (118 mL)

INGREDIENTS AND APPEARANCE

DYNA-HEX  2
chlorhexidine gluconate liquid

Product 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)