Active Ingredient
Chlorhexidine gluconate 2% solution
Antimicrobial Skin Cleanser Liquid
FDA Label NDC 21749-106
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gojo Industries, Inc. for the product Antimicrobial Skin Cleanser (NDC 21749-106). 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
- healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
- surgical hand scrub: reduce the number of microorganisms on the hands and forearms prior to surgery or patient care
Warnings
For external use only
Allergy alert:
This product may cause a severe alleric reaction. Symptoms may include:
- wheezing/difficulty breathting
- 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 ingredient in this product
When Using This Product
- keep out of eyes, ears and mouth. May cause serious and permenant eye injury if permitted to enter and remain in the eye or may cause deafness when instilled through the middle ear through perforated eardrums.
- if solution should contact these areas, rinse out promptly and thoroughly with water
- do not use routinely if you have wounds which involve more than the superficial layers 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 under 2 months of age. These products may cause irritation or chemical burns.
- wet hands and forearms with water
- scrub for 3 minutes with about 5 mL of product with or without a wet brush, paying close attention to the nails, cuticles and skin between the fingers
- a seperate nail cleaner may be used
- rinse thoroughly
- wash for an additional 3 minutes with 5 mL of product and rinse under running water
- rinse and dry thoroughly
- wet hands with water
- dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 15 seconds
- dry thoroughly
Surgical hand scrub:
Healthcare personnel handwash:
Other Safety Information
- store at 20-25°C (68-77°F)
- avoid excessive heat about 40°C (104°F)
Inactive Ingredients
citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water
Questions Or Comments?
call 1-800-321-9647 Monday through Friday 8:30 AM to 5:00 PM
Package Label.Principal Display Panel
NDC 21749-106-89
Chlorhexidine Gluconate 2% Solution
Antimicrobial SKin Cleanser
Distributed by:
Gojo Industries, Inc.
Akron, OH 44309
330-255-6000
www.gojo.com
NDC 21749-106-89
Chlorhexidine Gluconate 2% Solution
Antimicrobial SKin Cleanser
Distributed by:
Gojo Industries, Inc.
Akron, OH 44309
330-255-6000
www.gojo.com
NDC 21749-106-32
PROVON BRAND
Antimicrobial Skin Cleanser
Chlorhexidine Gluconate
2% Solution
Antiseptic
Distributed by:
GOJO Industries, Inc.
Akron, OH 44309
Questions?
Tel. 800-321-9647
*330-255-6000
www.GOJO.com
©2018. All rights reserved.
2PROV32BTLLBL
4104-12
Net Contents: 32 fl oz (1qt) (946 mL)
* Please review the disclaimer below.
