Label: CHLORHEXIDINE GLUCONATE SOLUTION 0.75% ANTISEPTIC solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 18, 2021

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  • Active ingredient

    Chlorhexidine gluconate solution, 0.75%

  • Purpose

    Antiseptic

  • Use

    • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • 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 ingredient in this product

    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
    • do not use routinely if you have wounds which involve more than the superficial layers of the skin

    Stop use and ask a 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 and infants under 2 months of age. These products may cause irritation or chemical burns.

    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
  • Other information

    • store at 20-25°C (68-77°F)
    • avoid excessive heat above 40°C (104°F)
  • Inactive ingredients

    citric acid, cocamide DEA, FD&C yellow #5, FD&C red #4, fragrance, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water, ricinoleamidopropyl trimethyl ammonium chloride

  • Questions or comments?

    call 1-800-581-2528, 24 hours a day, 7 days a week

  • Package/Label Principal Display Panel

    Dr. Dean

    Chlorhexidine Gluconate

    Solution

    0.75%

    Up to 6 Hour Protection

    Antimicrobial Skin Soap

    FOR EXTERNAL USE ONLY

    Distributed by USA Medical Supply

    Northbrook, IL 60062

    www.usamedicalsupply.com

    4 fl oz (118 mL)

    NDC 81657-001-01

    MADE IN THE USA

    FDA APPROVED

    California Prop 65 WARNING

    Keep from freezing.

    fourwht

    Dr. Dean

    Chlorhexidine Gluconate

    Solution

    0.75%

    Up to 6 Hour Protection

    Antimicrobial Skin Soap

    FOR EXTERNAL USE ONLY

    Distributed by USA Medical Supply

    Northbrook, IL 60062

    www.usamedicalsupply.com

    8 fl oz (236 mL)

    NDC 81657-001-02

    MADE IN THE USA

    FDA APPROVED

    California Prop 65 WARNING

    Keep from freezing.

    eightwht

    Dr. Dean

    Chlorhexidine Gluconate

    Solution

    0.75%

    Up to 6 Hour Protection

    Antimicrobial Skin Soap

    FOR EXTERNAL USE ONLY

    Distributed by USA Medical Supply

    Northbrook, IL 60062

    www.usamedicalsupply.com

    8 fl oz (236 mL)

    NDC 81657-001-04

    MADE IN THE USA

    FDA APPROVED

    California Prop 65 WARNING

    Keep from freezing.

    eightovl

    Dr. Dean

    Chlorhexidine Gluconate

    Solution

    0.75%

    Up to 6 Hour Protection

    Antimicrobial Skin Soap

    FOR EXTERNAL USE ONLY

    Distributed by USA Medical Supply

    Northbrook, IL 60062

    www.usamedicalsupply.com

    128 fl oz (3785 mL)

    NDC 81657-001-03

    MADE IN THE USA

    FDA APPROVED

    California Prop 65 WARNING

    Keep from freezing.

    galwht

    Keep from freezing.

    calstat

  • INGREDIENTS AND APPEARANCE
    CHLORHEXIDINE GLUCONATE SOLUTION 0.75% ANTISEPTIC 
    chlorhexidine gluconate solution 0.75% antiseptic solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81657-001(NDC:61037-414)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE0.75 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    RICINOLEAMIDOPROPYLTRIMONIUM CHLORIDE (UNII: 93OU7D1C3U)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81657-001-01118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/2014
    2NDC:81657-001-02236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/2014
    3NDC:81657-001-033785 mL in 1 JUG; Type 0: Not a Combination Product09/30/2014
    4NDC:81657-001-04236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/12/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02011109/30/2014
    Labeler - USA Medical Supply LLC (117790416)
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