ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate 4% liquid 
Kinray Inc.

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Drug Facts

Active Ingredients

Chlorhexidine Gluconate 4% Solution

Purpose

Antiseptic

Uses

Healthcare Professional 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 genral skin cleaning

Warnings

for external use only

Do not use

  • if you are alleric to chlorhexidine gluconate or any ohter 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, an mouth. Maycause seriously and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when installed in the middle ear thru perforated eardurms.
  • 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

Warning

This product contains a chemical known to the State of California to cause Cancer.

Directions

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

Healthcare personnel handwash:

Patient preoperative skin preparation:

Skin wound and normal skin cleansing:

Other information

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

Package label and principal display panel

Preferred Plus Pharmacy

NDC 61715-072-08

Antiseptic Skin Cleanser

(Chlorhexidine Gluconate 4% solution)

Antiseptic/Antimicrobial Skin Cleanser

for external use only

8FL OZ. (237 mL)

Do no use if seal is broken or missing

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ANTISEPTIC SKIN CLEANSER 
chlorhexidine gluconate 4% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-072
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE4 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
TRIDECYL ALCOHOL (UNII: 8I9428H868)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-072-08237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912508/03/2013
Labeler - Kinray Inc. (012574513)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories, Inc.007470579manufacture(61715-072)

Revised: 8/2013
Document Id: e193543e-cd2a-4a9d-af49-b351a5017f66
Set id: dfdaa646-0ef5-4433-b8d3-39ec139827b9
Version: 2
Effective Time: 20130801
 
Kinray Inc.