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Dyna-Hex

Xttirum Laboratories, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

 Chlorhexidine gluconate 2% Solution

Purposes

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

Dyna-Hex 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)

Dyna-Hex

Dyna-Hex

Dyna-Hex

Dyna-Hex

Dyna-Hex

Dyna-Hex

CHLORHEXIDINE GLUCONATE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0116-1021
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
chlorhexidine gluconate CHLORHEXIDINE 2 g

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
Coco Diethanolamide
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)
ISOPROPYL ALCOHOL
LAURAMINE OXIDE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0116-1021-04 118 in 1 BOTTLE, PLASTIC
2 NDC:0116-1021-08 237 in 1 BOTTLE, PLASTIC
3 NDC:0116-1021-16 473 in 1 BOTTLE, PLASTIC
4 NDC:0116-1021-17 473 in 1 BOTTLE, PLASTIC
5 NDC:0116-1021-32 946 in 1 BOTTLE, PLASTIC
6 NDC:0116-1021-01 15142 in 1 JUG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019422 2014-01-01


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