NDC 0116-0162 Antiseptic Skin Cleanser
Chlorhexidine Gluconate 4% Liquid Topical
What is NDC 0116-0162?
The NDC code 0116-0162 is assigned by the FDA to the product Antiseptic Skin Cleanser which is a human over the counter drug product labeled by Xttrium Laboratories, Inc.. The generic name of Antiseptic Skin Cleanser is chlorhexidine gluconate 4%. The product's dosage form is liquid and is administered via topical form. The product is distributed in a single package with assigned NDC code 0116-0162-08 237 ml in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Antiseptic Skin Cleanser?
This medication is used along with regular tooth brushing/flossing to treat gingivitis, a gum disease that causes red, swollen, and easily bleeding gums. Chlorhexidine belongs to a class of drugs known as antimicrobials. It works by decreasing the amount of bacteria in the mouth, helping to reduce swelling and redness of the gums and bleeding when you brush.
NDC Code 0116-0162-08
Package Description: 237 mL in 1 BOTTLE, PLASTIC
What are Antiseptic Skin Cleanser Active Ingredients?
Antiseptic Skin Cleanser Active Ingredients UNII Codes
- CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
- CHLORHEXIDINE (UNII: R4KO0DY52L) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 211365 - chlorhexidine gluconate 4 % Medicated Liquid Soap
- RxCUI: 211365 - chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap
- RxCUI: 211365 - chlorhexidine gluconate 4 % Medicated Surgical Scrub
Antiseptic Skin Cleanser Inactive Ingredients UNII Codes
- LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
- COCO DIETHANOLAMIDE (UNII: 92005F972D)
- PEG-75 LANOLIN (UNII: 09179OX7TB)
- HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
- ISOPROPYL ALCOHOL (UNII: ND2M416302)
- WATER (UNII: 059QF0KO0R)
- TRIDECYL ALCOHOL (UNII: 8I9428H868)
- GLUCONOLACTONE (UNII: WQ29KQ9POT)
* Please review the disclaimer below.
Antiseptic Skin Cleanser Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
Chlorhexidine gluconate 4% solution
- 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
For external use only
This product may cause a severe allergic reaction. Symptoms may include:
- wheezing/difficulty breathing
- facial swelling
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 of may cause deafness when instilled in the middle ear through perforated eatdrums.
- 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.
- 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
- 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 5 mL 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
Surgical hand scrub:
Healthcare personnel handwash:
Skin wound and normal skin cleansing:
- store at 20-25°C (68-77°F)
- avoid excessive heat above 40°C (104°F)
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
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 only non-chlorine detergents.
DIST. BY MEIJER DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
*This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.
Package Label And Principal Display Panel
Compare to the active ingredient in Hibiclens®*
Reduces bacteria on the skin
Antiseptic Skin Cleanser
Chlorhexidine Gluconate 4% Solution
Antiseptic/Antimicrobial Skin Cleanser
FOR EXTERNAL USE ONLY
8 FL OZ (237 mL)
TAMPER EVIDENT: DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING.
* Please review the disclaimer below.