IIMed 4-oz Dyna-Hex 2

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Chlorhexidine Gluconate 2% Solution

Purpose

Antiseptic

Uses

• 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 skin cleansing

Warnings

For external use only

Allergy alert:

This product may cause a severe allergic reaction. Symptoms may include:

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

• 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 eyes, ears, and mouth. May cause serious and permenent 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 advised by 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

Healthcare personnel handwash:

Patient preoperative skin preparation:

Skin wound and general skin cleaning:

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

Other information

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

Inactive ingredients

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

RECENT MAJOR CHANGES SECTION

Directions and Uses updated

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDA 0116-1021-04

DYNA-HEX 2 ®

(Chlorhexidine Gluconate 2% Solution)

Antiseptic

Contains: 2% Chlorhexidine Gluconate

FOR EXTERNAL USE ONLY

For single-use

Net Contents: 4 fl oz (118 mL)

Distributed By: Xttrium Laboratories, Inc. Mount Prospect, IL 60056 2BLDY04BTLLBLF