ANTISEPTIC SKIN CLEANSER CHLORHEXIDINE GLUCONATE XTTRIUM LABORATORIES, INC. FDA Approved 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 skin wound and general skin cleansing

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient Chlorhexidine gluconate
Inactive Ingredients
Inactive ingredients cocamide DEA fragrance glucono-delta-lactone hydroxyethylcellulose isopropyl alcohol lauramine oxide PEG-75 lanolin purified water tridecyl alcohol
Quantities
237 ml 473 ml 946 ml 118 ml 532 ml
Treats Conditions
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 Skin Wound And General Skin Cleansing

Identifiers & Packaging

Container Type UNKNOWN
UPC
0011610611609 0001161061404 0011610613207 0301161061085
UNII
MOR84MUD8E
Packaging

Package label and principal display panel NDC 0116-1061-08 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: 8 fl oz (237 mL) 4DY08BTLLBLF NDC 0116-1061-16 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: 16 fl oz (473 mL) 4DY16BTLLBLF NDC 0116-1061-32 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: 32 fl oz (946 mL) 4DY32BTLLBLB NDC 0116-1061-01 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: 128 fl oz (1 gal) 4DYN1GBTLLBLC NDC 0116-1061-40 DYNA-HEX 4® Chlorhexidine Gluconate 4% Solution Antiseptic Contains: 4% Chlorhexidine Gluconate With foam pump Distributed By: Xttrium Laboratories, Inc. Mount Prospect, IL 60056 FOR EXTERNAL USE ONLY Net Contents: 4 fl oz (118mL) 4DY04FM1061LBLB NDC 0116-1061-18 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: 18 fl oz (532mL) 4DY18FM1061LBLB 4 Dyna-Hex 8oz Single Panel 16oz Dyna-Hex 4 single panel Dyna-Hex 4 32oz 1 Gallon Dyna-Hex 4 4oz FM Dyna-Hex 4 18oz Dyna-Hex 4 single panel

Package Descriptions
  • Package label and principal display panel NDC 0116-1061-08 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: 8 fl oz (237 mL) 4DY08BTLLBLF NDC 0116-1061-16 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: 16 fl oz (473 mL) 4DY16BTLLBLF NDC 0116-1061-32 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: 32 fl oz (946 mL) 4DY32BTLLBLB NDC 0116-1061-01 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: 128 fl oz (1 gal) 4DYN1GBTLLBLC NDC 0116-1061-40 DYNA-HEX 4® Chlorhexidine Gluconate 4% Solution Antiseptic Contains: 4% Chlorhexidine Gluconate With foam pump Distributed By: Xttrium Laboratories, Inc. Mount Prospect, IL 60056 FOR EXTERNAL USE ONLY Net Contents: 4 fl oz (118mL) 4DY04FM1061LBLB NDC 0116-1061-18 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: 18 fl oz (532mL) 4DY18FM1061LBLB 4 Dyna-Hex 8oz Single Panel 16oz Dyna-Hex 4 single panel Dyna-Hex 4 32oz 1 Gallon Dyna-Hex 4 4oz FM Dyna-Hex 4 18oz Dyna-Hex 4 single panel

Overview

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 skin wound and general skin cleansing

Indications & Usage

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 skin wound and general skin cleansing

Dosage & Administration

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 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

Warnings & Precautions
Warnings For external use only Allergy alert: This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away. 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 (only in 4-oz) When using this product keep out of eyes, ears and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye 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.
Purpose

Purpose Antiseptic

Do Not Use

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 (only in 4-oz) 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

When Using

When using this product keep out of eyes, ears and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye 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 When using this product keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye 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 shold not be done except when advised by a health care provider

Stop Use & Ask a Doctor

Stop use and ask doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Storage & Handling

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

Questions

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


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