Label: MAXICLENS CHLORHEXIDINE GLUCONATE LIQUID SOLUTION, 4%- chlorhexidine gluconate solution
- NDC Code(s): 0404-0176-09
- Packager: Henry Schein, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated February 28, 2023
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- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses
surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
healthcare personnel handwash: handwash to help reduce bacteria that potentially can cause disease
skin wound and general skin cleanser: helps reduce bacteria on the skin - WARNINGS
- DO NOT USE
-
WHEN USING
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 contact occurs, rinse with cold water right away
- 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 an underlying condition makes it necessary to reduce the bacterial population of the skin
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
- use full strength
- do not dilute
Surgical hand scrub:
- remove jewelry
- wet hands and forearms with water and apply 5 mL of the product
- wash/scrub hands and forearms for 3 minutes paying particular attention to the nails, cuticles, and interdigital spaces
- rinse thoroughly with water
- wash for an additional 3 minutes with 5 mL of the product and rinse under running water
- dry thoroughly
Healthcare personnel handwash:
- wet hands with water
- dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 30 seconds
- rinse and dry thoroughly
Skin wound and general skin cleanser:
- thoroughly rinse the area to be cleansed with water
- apply the minimum amount of product necessary to cover the skin or wound area and wash gently. Rinse thoroughly with water.
- rinse again thoroughly
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
-
PRINCIPAL DISPLAY PANEL
NDC 0404-0176-09
MaxiclensTM
Antiseptic Skin Cleanser
(Chlorhexidine Gluconate 4%)
FOR EXTERNAL USE ONLY
Distributed By
HENRY SCHEIN INC.
135 Duryea Road
Melville, NY 11747 USA
Net Contents
128 fl oz (1 gal) (3.785 L)
Made in U.S.A.
Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach. Rinse completely and use only non-chlorine detergents.
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.ca.govProduct Made in U.S.A.
Keep from freezing. -
INGREDIENTS AND APPEARANCE
MAXICLENS CHLORHEXIDINE GLUCONATE LIQUID SOLUTION, 4%
chlorhexidine gluconate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0404-0176 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength COCO DIETHANOLAMIDE (UNII: 92005F972D) WATER (UNII: 059QF0KO0R) GLUCONIC ACID (UNII: R4R8J0Q44B) QUATERNIUM-33 (UNII: XPS4174QZJ) GLUCONOLACTONE (UNII: WQ29KQ9POT) PEG-75 LANOLIN (UNII: 09179OX7TB) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ISOPROPYL ALCOHOL (UNII: ND2M416302) COCAMINE OXIDE (UNII: QWA2IZI6FI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0404-0176-09 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/17/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019258 11/17/2021 Labeler - Henry Schein, Inc. (012430880)