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Antiseptic Skin Cleanser by Walgreen Co.

Dosage form: liquid
Ingredients: CHLORHEXIDINE GLUCONATE 4mg in 100mL
Labeler: Walgreen Co.
NDC Code: 0363-1061

Walgreens 1061

Active Ingredient

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
  • skin wound and general skin cleansing

Warnings

For external use only

Allergy alert:

This product may cause a severe allergic reaction. Sypmtoms 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 of the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
  • in contact with meninges
  • in the genital area

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.

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 5 mL of product into cupped hands and wash in a vigorous manner for about 15 seconds
  • rinse and dry thoroughly

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, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.

Questions or comments?

call 1-800-925-4733

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

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

‡Walgreens Pharmacist Survey Study, November 2014

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

Distributed by: Walgreen Co.

200 Wilmot RD., Deerfield, IL 60015

100% Satisfaction Guaranteed

walgreens.com

©2015 Walgreen Co. Made in USA

Package label and principal display panel

Well at Walgreens

NDC 0363-1061-08

Walgreens Pharmacist Recommended‡

Antiseptic Skin Cleanser

Chlorhexidine Gluconate 4% Solution/Antiseptic/Antimicrobial Skin Cleanser

Compare to the active ingredient in Hibiclens®‡‡

8 FL OZ. (237 mL)

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING.

4WA08BTLLBLF

Well at Walgreens

NDC 0363-1061-16

Walgreens Pharmacist Recommended‡

Antiseptic Skin Cleanser

Chlorhexidine Gluconate 4% Solution/Antiseptic/Antimicrobial Skin Cleanser

Compare to the active ingredient in Hibiclens®‡‡

16 FL OZ. (473 mL)

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING.

4WA16BTLLBLC

Carton

NDC 0363-1061-15

Walgreens, Co.

Chlorhexidine Gluconate 4% Solution

Antiseptic Skin Cleansing Kit

Distributed by:

Xttrium Laboratories, Inc.,

Mount Prospect, IL 60056

4WAL15INNERCTN

0.5 FL OZ (15 mL)

Lidstock

NDC 0363-1061-15

Walgreens, Co.

Chlorhexidine Gluconate 4% Solution

Antiseptic Skin Cleansing Kit

Distributed by:

Xttrium Laboratories, Inc.,

Mount Prospect, IL 60056

4WAL15LIDSTOCK

0.5 FL OZ (15 mL)

Packet

NDC 0363-1061-15

Walgreens, Co.

Chlorhexidine Gluconate 4% Solution

Antiseptic Skin Cleansing Convenience Kit

Distributed by:

Xttrium Laboratories, Inc.,

Mount Prospect, IL 60056

4WAL15PACKET
0.5 FL OZ (15 mL)

ANTISEPTIC SKIN CLEANSER 
chlorhexidine gluconate 4% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1061
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
LAURAMINE OXIDE 
COCO DIETHANOLAMIDE 
PEG-75 LANOLIN 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
ISOPROPYL ALCOHOL 
WATER 
TRIDECYL ALCOHOL 
GLUCONOLACTONE 
Packaging
#Item CodePackage Description
1NDC:0363-1061-08237 mL in 1 BOTTLE, PLASTIC
2NDC:0363-1061-16473 mL in 1 BOTTLE, PUMP
3NDC:0363-1061-1515 mL in 1 KIT
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912505/01/2011
Labeler - Walgreen Co. (008965063)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIOperations
Xttrium Laboratories, Inc.007470579manufacture(0363-1061)

 
Walgreen Co.

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Medically reviewed on Oct 31, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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