FDA Label for Antiseptic Skin Cleanser
View Indications, Usage & Precautions
Antiseptic Skin Cleanser Product Label
The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
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
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 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, 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 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
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
- 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
- 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
- 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
Healthcare personnel handwash:
Patient preoperative skin preparation:
Skin wound and normal skin cleansing:
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
Other Safety Information
Warning: This product contains a chemical (cocamide DEA) known to the State of California to cause cancer.
Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products. Rinse completely and use non-chlorine detergents.
*This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.
Package Label.Principal Display Panel
Sunmark
Compare to the active ingredient in Hibiclens®*
NDC 49348-115-37
antiseptic skin cleanser
Chlorhexidine Gluconate 4% Solution
Antiseptic/Antimicrobial Skin Cleanser
Dye free
FOR EXTERNAL USE ONLY
NET CONTENTS: 8 FL OZ (237 mL)
* Please review the disclaimer below.