ANTISEPTIC SKIN CLEANSER

Xttrium Laboratories, Inc.
Xttrium Laboratories, Inc.

Drug Fact

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredient
• Purpose
• ANTISEPTIC SKIN CLEANSER Uses
• Warnings
  • Do not use
  • When using this product
  • Stop use and ask a doctor
  • Keep out of reach of children
• Direction
• ANTISEPTIC SKIN CLEANSER Other information
• Inactive ingredients
• Questions or comments?
• Package label and principal display panel
• Package label and principal display panel

FULL PRESCRIBING INFORMATION

Active Ingredient

Chlorhexidine Gluconate

Purpose

Antiseptic

ANTISEPTIC SKIN CLEANSER 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: for the preparation of the patient's skin prior to surgeryskin wound and general skin cleansing
• skin wound and general skin 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
• 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 the underlying condition makes it necessary to reduce the bacterial population of skin

Stop use and ask a doctor

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

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 with water
• scrub for 3 minutes with about 5 ml of product 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 product and rinse under running water
• 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 procedure for an additional 2 minutes and dry with a sterile towel

Skin wound and general skin cleaning:

• 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

ANTISEPTIC SKIN CLEANSER Other information

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

Inactive ingredients

 cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

Questions or comments?

call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST

Package label and principal display panel

NDC 0116-1061-04

DYNA-HEX 4^®

(Chlorhexidine Gluconate 4% Solution)

Antiseptic

Contains: 4% Chlorhexidine Gluconate

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

FOR EXTERNAL USE ONLY

Net Contents: 4 fl oz (118 ml)

Package label and principal display panel

NDC 0116-1061-09

CVS Pharmacy

ANTISEPTIC SKIN CLEANSER

(CHOLORHEXIDINE GLUCONATE 4% SOLUTION)

ANTISEPTIC/ ANTIMICROBIAL SKIN CLEANSER

For External Use Only

8FL OZ (237 mL) Tamper evident, do not use if imprinted shrink seal neckband is broken or missing.