Your browser does not support JavaScript! ANTISEPTIC SKIN CLEANSER (CHLORHEXIDINE GLUCONATE) LIQUID [CARDINAL HEALTH]
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ANTISEPTIC SKIN CLEANSER (chlorhexidine gluconate) liquid
[Cardinal Health]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL New Drug Application
Drug Label Sections

Active Ingredient

Chlorhexidine Gluconate 4% Solution

Purpose

Antiseptic

Uses

  • 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 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.

Directions

Healthcare personnel handwash:

  • wet hands with water
  • dispense about 5 ml of product into cupped hands and wash in a vigorous manner for about 15 seconds
  • rinse and dry thoroughly

Patient preoperative skin preparation:

  • apply product liberally to surgical site and swab for at lease 2 minutes
  • dry with a sterile towel
  • repeat the procedure for an additional 2 minutes and dry with a sterile towel

Skin wound and general skin cleansing:

  • throughly rinse the area to be cleaned with water
  • apply the minimum amount of the product necessary to cover the skin and wound area and wash gently
  • rinse again and thoroughly

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 CST, Monday through Friday 8:00 AM to 4:30 PM

Principal Display

NDC 37205-595-34

Leader®

Antiseptic Skin Cleanser

(Chlorhexidine Gluconate 4% Solution)

Antiseptic/Antimicrobial Skin Cleanser

For External Use Only

8FL OZ (237mL)

Distributed By Cardinal Health

Dublin, Ohio 43017

CIN 4530226

www.myleader.com

1-800-200-6313

4LEADERBTLLBL

All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

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ANTISEPTIC SKIN CLEANSER 
chlorhexidine gluconate liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:37205-595
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE4 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
COCO DIETHANOLAMIDE 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
ISOPROPYL ALCOHOL 
WATER 
TRIDECYL ALCOHOL 
GLUCONOLACTONE 
PEG-75 LANOLIN 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-595-34237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912501/01/2012
Labeler - Cardinal Health (097537435)
Registrant - Xttrium Laboratories, Inc. (005140611)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories, Inc.005140611manufacture(37205-595)

Revised: 9/2012
 
Cardinal Health

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