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 Rite Aid. 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 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. 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 or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
- in contact with the 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 ete or may cause deafness when instilled in the middle ear through perforated eardurms.
- 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 healthcare 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 two months of age. These products may cause irritation or chemical burns.
- wet hands and forearms with water
- scrub for 3 minutes with 4 full pumps (6 grams) of product and a wet brush paying close attention to the nails, cuticles, and interdigital spaces
- a seperate nail cleaner may be used
- rinse thoroughly
- was for an additional 3 minutes with 4 full pumps(6 grams) of product and rinse under running water
- dry thoroughly
- wet hands with water
- dispense 4 full pumps (6 grams) of product into cupped hands and wash in a vigrous manner for 15 seconds
- rinse and dry thoroughly
- 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:
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
cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol
Questions Or Comments?
call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST
Package Label.Principal Display Panel
Compare to the active ingredient in Hibiclens®*
NDC 11822-0891-2
ANTISEPTIC/ANTIMICROBIAL
SKIN CLEANSER
CHLORHEXIDINE GLUCONATE
4% SOLUTION
dye free
for external use only
TAMPER-EVIDENT: DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING
18 FL OZ (532 mL)
4RA18FM1061LBL
* Please review the disclaimer below.