Active Ingredient
Chlorhexidine gluconate 2% solution
Cardinal Health Antiseptic Skin Cleanser
FDA Label NDC 63517-113
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Cardinal Health Antiseptic Skin Cleanser (NDC 63517-113). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
- 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 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
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.
- 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
- 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
- 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
- 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
Surgical hand scrub:
Healthcare personnel handwash:
Patient preoperative skin preparation:
Skin wound and general skin cleansing:
Other Information
- store at 20-25°C (68-77°F)
- avoid excessive heat above 40°C (104°F)
Inactive Ingredients
citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water
Other Safety Information
WARNING: This product contains a chemical (cocamide DEA) known to the State of California to cause cancer.
For Professional and Hospital Use
You may report serious side effects to 1-877-227-3462
Package Label
NDC: 63517-113-04
Chlorhexidine Gluconate 2% Solution
antiseptic
Cat. AS 2CHGL4
Distributed by:
Cardinal Health™
Waukegan, IL 60085 USA
cardinalhealth.com
Rev. A 02\16
2CHA04BTLLBLA
Net Wt 4 fl oz (118 mL)
NDC: 63517-113-08
Chlorhexidine Gluconate 2% Solution
antiseptic
Cat. AS 2CHGL8
Distributed by:
Cardinal Health™
Waukegan, IL 60085 USA
cardinalhealth.com
Rev. A 02\16
2CHA08BTLLBLA
Net Wt 8 fl oz (237 mL)
NDC: 63517-113-16
Chlorhexidine Gluconate 2% Solution
antiseptic
Cat. AS 2CHGL16
Distributed by:
Cardinal Health™
Waukegan, IL 60085 USA
cardinalhealth.com
Rev. A 02\16
2CHA16BTLLBLA
Net Wt 16 fl oz (473 mL)
NDC: 63517-113-32
Chlorhexidine Gluconate 2% Solution
antiseptic
Cat. AS 2CHGL32
Distributed by:
Cardinal Health™
Waukegan, IL 60085 USA
cardinalhealth.com
Rev. A 02\16
2CHA32BTLLBLA
Net Wt 32 fl oz (946mL)
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