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Antiseptic Skin Cleanser by Kinray Inc.

Dosage form: liquid
Ingredients: CHLORHEXIDINE GLUCONATE 4mg in 100mL
Labeler: Kinray Inc.
NDC Code: 61715-072

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:

  • 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

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

ANTISEPTIC SKIN CLEANSER 
chlorhexidine gluconate 4% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-072
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: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/FEIOperations
Xttrium Laboratories, Inc.007470579manufacture(61715-072)

Revised: 08/2013
 
Kinray Inc.

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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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