Label: BETASEPT- antiseptic surgical scrub solution

  • NDC Code(s): 67618-200-01, 67618-200-04, 67618-200-08, 67618-200-16, view more
    67618-200-30, 67618-200-32
  • Packager: Avrio Health L.P.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 28, 2022

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    Drug Facts
    Active ingredient Purpose
    Chlorhexidine gluconate 4% solution

  • ACTIVE INGREDIENT

  • PURPOSE

    Purpose
    Antiseptic

  • WHEN USING

    Uses

    • 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
  • WARNINGS

    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

    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

    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
    • 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

    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • OTHER SAFETY INFORMATION

    Directions

    • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
  • INDICATIONS & USAGE

    Surgical hand scrub:

    • wet hands and forearms with 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
  • DOSAGE & ADMINISTRATION

    Healthcare personnel handwash:

    • wet hands with water
    • dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 15 seconds
    • rinse and dry thoroughly
  • DOSAGE FORMS & STRENGTHS

    Skin wound and general skin cleansing:

    • 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
  • OTHER SAFETY INFORMATION

    Other information

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

    Inactive ingredients cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

    Questions or comments? call 1-888-827-0624 (8am-5pm, EST, Mon-Fri.)

    WARNING: This product can expose you to chemicals including 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

    Dist. by: Avrio Health L.P. Stamford, CT 06901-3431

    304978-0A

  • PRINCIPAL DISPLAY PANEL

    BETASEPT
    Antiseptic Surgical Scrub
    NDC: 67618–200–30

    304978-0A
  • INGREDIENTS AND APPEARANCE
    BETASEPT 
    antiseptic surgical scrub solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Chlorhexidine Gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L) Chlorhexidine Gluconate.04 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    WATER (UNII: 059QF0KO0R)  
    TRIDECYL ALCOHOL (UNII: 8I9428H868)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67618-200-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1993
    2NDC:67618-200-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1993
    3NDC:67618-200-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1993
    4NDC:67618-200-30946 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1993
    5NDC:67618-200-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/199301/31/2023
    6NDC:67618-200-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/199305/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01912506/01/1993
    Labeler - Avrio Health L.P. (141916531)
    Registrant - Purdue Pharma LP (932323652)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium Laboratories, Inc.007470579MANUFACTURE(67618-200)