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Antiseptic Skin Cleanser by McKesson

Dosage form: liquid
Ingredients: CHLORHEXIDINE GLUCONATE 4mg in 100mL
Labeler: McKesson
NDC Code: 49348-115

Drug Facts

Active Ingredients

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

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 surgery

skin wound and general skin cleansing

Warnings

For external use only

Do not use
  • if you are allergic to chlorhexidine gluconate or any other ingredient
  • in contact with meninges
  • in 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 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:

  • wet hands and forearms under running 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 5ml of product into cupped hands and wahs in vigorous manner for about 15 seconds
  • rinse and dry thoroughly

Patient preoperative skin preparation:

  • apply product librally 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 normal 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

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

Questions of comments?

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

Warning: This product contains a chemical (cocamide DEA) known to the State of California to cause cancer.

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products. Rinse completely and use non-chlorine detergents.

*This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.

Sunmark

Compare to the active ingredient in Hibiclens®*

NDC 49348-115-37

antiseptic skin cleanser

Chlorhexidine Gluconate 4% Solution

Antiseptic/Antimicrobial Skin Cleanser

Dye free

FOR EXTERNAL USE ONLY

NET CONTENTS: 8 FL OZ (237 mL)

ANTISEPTIC SKIN CLEANSER 
chlorhexidine gluconate 4% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-115
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE4 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
COCO DIETHANOLAMIDE 
PEG-75 LANOLIN 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
ISOPROPYL ALCOHOL 
WATER 
TRIDECYL ALCOHOL 
GLUCONOLACTONE 
Packaging
#Item CodePackage Description
1NDC:49348-115-37237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912502/20/2014
Labeler - McKesson (177667227)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIOperations
Xttrium Laboratories, Inc.007470579manufacture(49348-115)

Revised: 12/2015
 
McKesson

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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