Label: CHLORHEXIDINE GLUCONATE solution
- NDC Code(s): 16571-111-12, 16571-111-24, 16571-111-48, 16571-111-95
- Packager: Rising Pharma Holdings, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated August 11, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purposes
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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
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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 are allergic to chlorhexidine gluconate or any other ingredients in this preparation
- as a patient properative skin preparation (especially on the head or face)
- 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 placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated ear drums
- 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 underlying condition makes it necessary to reduce the bacterial population of the skin
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Directions
- use with care in premature infants or infants under 2 months of age. These product 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
- Other information
- Inactive ingredients
-
Questions or comments?
Call 1-884-874-7464 Monday through Friday 8:00 AM to 5:00 PM EST
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.gov
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.
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816Keep from freezing.
Issued: 07/2023
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PRINCIPAL DISPLAY PANEL
Chlorhexidine Gluconate Liquid Solution
NDC:16571-111-12; 118 mL in 1 BOTTLE
Chlorhexidine Gluconate Liquid Solution
NDC:16571-111-24; 236 mL in 1 BOTTLE
Chlorhexidine Gluconate Liquid Solution
NDC:16571-111-48; 473 mL in 1 BOTTLE
Chlorhexidine Gluconate Liquid Solution
NDC:16571-111-95; 946 mL in 1 BOTTLE
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INGREDIENTS AND APPEARANCE
CHLORHEXIDINE GLUCONATE
chlorhexidine gluconate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16571-111 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 COCAMINE OXIDE (UNII: QWA2IZI6FI) GLUCONOLACTONE (UNII: WQ29KQ9POT) PEG-75 LANOLIN (UNII: 09179OX7TB) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) COCO DIETHANOLAMIDE (UNII: 92005F972D) GLUCONIC ACID (UNII: R4R8J0Q44B) HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) QUATERNIUM-33 (UNII: XPS4174QZJ) ISOPROPYL ALCOHOL (UNII: ND2M416302) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16571-111-12 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/26/2023 2 NDC:16571-111-24 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/26/2023 3 NDC:16571-111-48 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/26/2023 4 NDC:16571-111-95 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/26/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019258 07/26/2023 Labeler - Rising Pharma Holdings, Inc. (116880195)