Label: OROMIN- calcium chloride, sodium fluoride, sodium phosphate rinse

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

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Drug Label Information

Updated June 13, 2017

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  • Recommended use:

    Oro Min is a remineralizing and anti-cavity fluoride rinse. It provides essential minerals necessary to harden teeth and promote remineralizing of tooth surfaces.

  • PURPOSE

    ORO Min is a remineralizing and anti-cavity fluoride rinse. It provides essential minerals necessary to harden teeth and promote remineralizing of tooth surfaces.

  • Medicinal ingredient:

    Calcium chloride 0.054%, sodium fluoride 0.02%, sodium phosphate 0.056%

  • Non-Medicinal Ingredients:

    Water, ethyl alcohol, sorbitol solution, sodium chloride, edetate disodium, sodium benzoate, polysorbate 20, polysorbate 80, methyl paraben, sodium saccharin, propyl paraben, and flavouring agent.

  • Directions:

    After brushing and flossing, rinse 10-15 mL of ORO Min (fill cap 3/4 full) between teeth for 60 seconds, then spit out. Do not swallow. Do not eat or drink for 30 minutes after rinsing. Use twice a day or as directed by your dentist or hygienist.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • WARNINGS

    Do not use if tamper-evident foil seal is broken. Do not store in direct sunlight.

  • PRINCIPAL DISPLAY PANEL

    500 mL50 mL

  • INGREDIENTS AND APPEARANCE
    OROMIN 
    calcium chloride, sodium fluoride, sodium phosphate rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61508-0200
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC0.056 g  in 100 g
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CHLORIDE0.054 g  in 100 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.01 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M) 2 g  in 100 g
    PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.005 g  in 100 g
    METHYLPARABEN (UNII: A2I8C7HI9T) 0.06 g  in 100 g
    DISODIUM ETHYLENEDIAMINEDIACETATE (UNII: EQL53S5L0F) 0.137 g  in 100 g
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.877 g  in 100 g
    SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.025 g  in 100 g
    WATER (UNII: 059QF0KO0R) 94.9 g  in 100 g
    SORBITOL (UNII: 506T60A25R) 1.5 g  in 100 g
    POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.1 g  in 100 g
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.1 g  in 100 g
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.1 g  in 100 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61508-0200-1500 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/16/2017
    2NDC:61508-0200-250 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/16/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/16/2017
    Labeler - Germiphene Corporation (206412512)
    Establishment
    NameAddressID/FEIBusiness Operations
    Germiphene Corporation206412512manufacture(61508-0200)
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