Label: CARDINAL HEALTH ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate 2% solution
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Contains inactivated NDC Code(s)
NDC Code(s): 63517-113-04, 63517-113-08, 63517-113-16, 63517-113-32 - Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated July 23, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
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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
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Warnings
For external use only
Allergy alert:
This product may cause a severe allergic reaction. Symptoms 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 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 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 the skin
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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 for 30 seconds. Clean fingernails using a nailstick or similar cleaner.
- scrub for 1.5 minutes with about 8 mL of product with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers
- rinse thoroughly under running water for 30 seconds
- wash for an additional 1.5 minutes with 8 mL of product and rinse under running water for 30 seconds
- 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 15 seconds
- rinse and dry thoroughly
Patient preoperative skin preparation:
- apply product liberally 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 general 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
- Inactive ingredients
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OTHER SAFETY INFORMATION
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 can expose you to chemicals including coconut oil diethanolamine condensate (cocamide diethanolamine/cocamide DEA), which is known to the State of California to cause cancer. For more information, go to P65Warnings.ca.gov
For Professional and Hospital Use
You may report serious side effects to 1-877-227-3462
Not made with natural rubber latex
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Package Label
NDC: 63517-113-04
AS-2CHGL4
Cardinal Health
Chlorhexidine Gluconate
2% Solution
Single Use Antiseptic
Non Sterile Solution
Distributed by: Cardinal Health
Waukegan, IL 60085 USA
Rev. D 2019-06 • cardinalhealth.com
© 2019 Cardinal Health. All Rights Reserved.
CARDINAL HEALTH and the Cardinal Health LOGO
are trademarks of Cardinal Health and may be
registered in the US and/or in other countries.
4 fl oz (118 mL)
NDC: 63517-113-08
AS-2CHGL8
Cardinal Health
Chlorhexidine Gluconate
2% Solution
Antiseptic
8 fl oz (237 mL)
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INGREDIENTS AND APPEARANCE
CARDINAL HEALTH ANTISEPTIC SKIN CLEANSER
chlorhexidine gluconate 2% solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63517-113 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength LAURAMINE OXIDE (UNII: 4F6FC4MI8W) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) COCO DIETHANOLAMIDE (UNII: 92005F972D) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63517-113-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2015 2 NDC:63517-113-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2015 3 NDC:63517-113-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2015 05/31/2019 4 NDC:63517-113-32 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2015 05/31/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019422 05/01/2015 Labeler - Cardinal Health (097537435) Registrant - Xttrium Laboratories, Inc. (007470579) Establishment Name Address ID/FEI Business Operations Xttirum Laboratories, Inc. 007470579 manufacture(63517-113)