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 Xttrium Laboratories, Inc.. 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
- 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 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 eye 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 advised by a health care provider
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.
- wet hands with water
- dispense about 5ml of product into cupped hands and wash in vigorous manner for about 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
Healthcare personnel handwash:
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, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.
Questions Of Comments?
call 1-773-268-5800 Monday through Friday 8:00 AM to 4:30 PM CST
Other Safety Information
Warning: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.gov
Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products. Rinse completely and use only non-chlorine detergents.
*Good Neighbor Pharmacy® Antiseptic Skin Cleanser is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.
Package Label And Principal Display Panel
Good Neighbor Pharmacy
NDC 46122-0137-34
Antiseptic Skin Cleanser
(Chlorhexidine Gluconate 4% solution)
Antiseptic/Antimicrobial Skin Cleanser
8 FL OZ. (237 mL) BOTTLE
FOR EXTERNAL USE ONLY
DYE FREE
TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING
4GNP08BTLLBLE
* Please review the disclaimer below.