Label: DR. DEAN- chlorhexidine gluconate liquid solution 2% solution
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Contains inactivated NDC Code(s)
NDC Code(s): 81657-002-01, 81657-002-02, 81657-002-03 - Packager: USA Medical Supply LLC
- This is a repackaged label.
- Source NDC Code(s): 42939-127
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated June 19, 2021
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- Official Label (Printer Friendly)
- Active ingredient
- Purposes
-
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 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 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 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
- washfor 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 INGREDIENT
- QUESTIONS
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Representative label and principal display panel
Dr. Dean
Chlorhexidine Gluconate
Liquid Solution
2.0%
Up to 6 Hour Protection
Antimicrobial Skin Soap
FOR EXTERNAL USE ONLY
Distributed by USA Medical Supply
Northbrook IL 60062
www.usamdsupply.com
4 FL OZ (118 mL)
NDC 81657-002-01
MADE IN THE USA
FDA APPROVED
Dr. Dean
Chlorhexidine Gluconate
Liquid Solution
2.0%
Up to 6 Hour Protection
Antimicrobial Skin Soap
FOR EXTERNAL USE ONLY
Distributed by USA Medical Supply
Northbrook IL 60062
www.usamdsupply.com
8 FL OZ (236 mL)
NDC 81657-002-02
MADE IN THE USA
FDA APPROVED
Dr. Dean
Chlorhexidine Gluconate
Liquid Solution
2.0%
Up to 6 Hour Protection
Antimicrobial Skin Soap
FOR EXTERNAL USE ONLY
Distributed by USA Medical Supply
Northbrook IL 60062
www.usamdsupply.com
128 FL OZ (3785 mL)
NDC 81657-002-03
MADE IN THE USA
FDA APPROVED
-
INGREDIENTS AND APPEARANCE
DR. DEAN
chlorhexidine gluconate liquid solution 2% solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81657-002(NDC:42939-127) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength COCO DIETHANOLAMIDE (UNII: 92005F972D) COCAMINE OXIDE (UNII: QWA2IZI6FI) GLUCONIC ACID (UNII: R4R8J0Q44B) GLUCONOLACTONE (UNII: WQ29KQ9POT) HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT) ISOPROPYL ALCOHOL (UNII: ND2M416302) PEG-75 LANOLIN (UNII: 09179OX7TB) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) QUATERNIUM-33 (UNII: XPS4174QZJ) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81657-002-01 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/22/1986 2 NDC:81657-002-03 3785 mL in 1 JUG; Type 0: Not a Combination Product 07/22/1986 3 NDC:81657-002-02 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/22/1986 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019258 07/22/1986 Labeler - USA Medical Supply LLC (117790416)