Label: SCRUB- chlorhexidine gluconate solution

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

Drug Label Information

Updated October 26, 2014

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  • Active ingredient

    chlorhexidine gluconate 0.75% solution

  • Purposes

    Antispetic

  • Uses

    • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • Warnings

    For external use only.

    Do not use

    • if you are allergic to chlorhexidine gluconate or any other ingredients
    • in contact with meninges
    • in the genital area
    • as a preoperative skin preparation (especially on the head and face)
    • on skin wonds
    • general skin cleanser as surgical hand scrub

    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 solution should contact these areas, rinse out promptly and thoroughly with water

    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.

    Other safety information

    This product contains a chemical known to the State of California to cause Cancer.

  • 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

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

  • Questions of Comments?

    Call 1-855-332-2525 Monday through Friday7:00 AM to 3:30 PM

  • Package/Label Principal Display Panel

    NDC 61037-412-01

    SCRUB™

    FROM HOSTIPTAL TO HOME

    Antiseptic Handwash

    Chlorhexidine Gluconate 0.75% Solution

    FDA Approved Antiseptic Handwash

    Contains: 0.75% Chlorhexidine Gluconate

    Distributed by: Bajaj Medical, LLC

    415 W. Pershing Rd.,

    Chicago, IL 60609

    FOR EXTERNAL USE ONLY

    Net Contents: 4 fl oz (118 ml)

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  • INGREDIENTS AND APPEARANCE
    SCRUB 
    chlorhexidine gluconate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61037-412
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE.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:61037-412-01118 mL in 1 BOTTLE, PLASTIC
    2NDC:61037-412-02237 mL in 1 BOTTLE, PLASTIC
    3NDC:61037-412-03473 mL in 1 BOTTLE, PLASTIC
    4NDC:61037-412-04946 mL in 1 BOTTLE, PLASTIC
    5NDC:61037-412-053785 mL in 1 JUG
    6NDC:61037-412-06237 mL in 1 BOTTLE, PUMP
    7NDC:61037-412-07237 mL in 1 BOTTLE, PUMP
    8NDC:61037-412-1060 mL in 1 BOTTLE, PUMP
    9NDC:61037-412-1160 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02011109/30/2014
    Labeler - Bajaj Medical, LLC (078774921)
    Registrant - Bajaj Medical, LLC (078774921)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bajaj Medical, LLC078774921manufacture(61037-412)
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