Label: BDFERM BIOSPRAY- calcium oxide spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 27, 2023

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  • Active Ingredients

    Calcium Oxide 0.295%

  • Purposes

    Reduces bacterial and viral growth in the mouth.

  • Uses

    Spray it two to four times a day in the mouth and on hands.

  • Storage and Handling

    Avoid direct sunlight and store it in a cool place.

  • Inactive Ingredients

    Purified water, BD FERM LEVAN K, BE FERM SYNBIOTICS, green grape scent

  • Directions

    Spray it two to four times a day in the mouth and on hands.

  • warnings

    for external use only : wash it as soon as it gets into your eyes.

    Warnings

    Stop use and ask a doctor if irritation or rash occurs.

    Warnings

    Do not use on damaged or irritated skin.

    Warnings

    Keep out of reach of children.

  • When using

    When using this product avoid contact with the eyes.

  • Pakage Label 82332-102

    82332-102

  • INGREDIENTS AND APPEARANCE
    BDFERM BIOSPRAY 
    calcium oxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82332-102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIME (CALCIUM OXIDE) (UNII: C7X2M0VVNH) (LIME (CALCIUM OXIDE) - UNII:C7X2M0VVNH) LIME (CALCIUM OXIDE)0.295 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    BACILLUS SUBTILIS (UNII: 8CF93KW41W)  
    LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5)  
    ASPERGILLUS FLAVUS VAR. ORYZAE (UNII: Q6Z8UK5R3G)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82332-102-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/18/2021
    Labeler - BDFERM CO.,ltd (694514861)