4-oz DYNA-HEX 4%

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Chlorhexidine gluconate 4% solution

Purpose

Antiseptic

Uses

• surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
• healhcare personnel handwash: helps reduce bacteria that potentially can cause disease
• patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery
• skin wound and general skin cleansing

Warnings

For external use only

Alergy alert:

This product may cause a severe allergic reaction. Symptoms may incloude

if an allergic reaction occurs, stop use and seek medical help right away

• wheezing/difficulty breathing
• shock
• facial swelling
• hives
• rash

Do not use

• if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
• 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 the eyes, ears and mouth. May cause serious and permenant eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated ear drums.
• if solution should contact these areas, rinse our 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 ecept when advised be a health care provider

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.

Directions

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

Surgical hand scrub:

Healthcare personnel handwash:

Patient preoperative skin preparation:

Skin wound and general skin cleaning:

• 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 amd interdigital spaces
• a seprate 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

Other information

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

Inactive ingredients

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0116-1061-04

DYNA-HEX 4 ®

(Chlorhexidine Gluconate 4% Solution)

Antiseptic

Contains: 4% Chlorhexidine Gluconate

Distributed by: Xttrium Laboratories, Inc.,

FOR EXTERNAL USE ONLY

Net Contents: 4 fl oz (118 mL)

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