Label: OPRECARE 3SET (07,12,21)- sodium monofluorophosphate, silicon dioxide kit

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

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Drug Label Information

Updated October 12, 2017

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  • Active ingredient

    Active ingredients 
     O'PRECARE 07   Sodium Monofluorophosphate (0.6%)
     O'PRECARE 12    Silica (Silicon dioxide) (2.85%)
     O'PRECARE 21 Sodium Monofluorophosphate (0.6%)

  • Purpose

    Anticavity

  • Warnings

    When using this product, if irritation occurs stop use and ask a dentist. Do not swallow, and rinse enough after use. Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional assistance or contact a Poison Control Center right away.

  • Uses

    Helps protect against cavities, plaque, gingivitis

  • Directions

    Directions 
     Adults and children 2 years of age and older Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
     Children 2 to 6 years Use only a pea sized amount and supervise childs brushing and rinsing (to minimize swallowing)
     Children under 2 years Ask a dentist or physician

  • Keep out of reach of children

    Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional assistance or contact a Poison Control Center right away.

  • Inactive ingredients

    Inactive ingredients 
     O'PRECARE 07                                                 Silica, Tocopheryl Acetate, Piridokssin Hydrochloride, Sodium Pyrophosphate, Sorbitol, PEG-32, Hydrated Silica, Cellulose Gum, Titanium Oxide, Xylitol, Stevioside, Camellia Sinensis Leaf Extract, Sodium Methyl Cocoyl Taurate, Ubidecarenone, Cnidium Extract, Menthol, Mint Flavor (Fragrance), Chamomilla Recutita (Matricaria) Flower Extract, Peppermint Flavor (fragrance), D.I-WATER
     O'PRECARE 12 Tocopheryl Acetate, Sorbitol, PEG-32, Cellulose Gum, Hydrated Silica, Stevioside, Xylitol, Sodium Methyl Cocoyl Taurate, Hydroxylapatite, Calcium Carbonate, Propolis Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Salvia Officinalis (SAGE) Extract, Pomegranate Extract, Spearmint Flavor (fragrance), Lemon Flavor (fragrance), Orange Oil, Menthol, Mastic Oil, D.I-WATER
     O'PRECARE 21 Silica, Tocopheryl Acetate, Piridokssin Hydrochloride, Sodium Pyrophosphate, Sorbitol, PEG-32, Hydrated Silica, Cellulose Gum, Titanium Oxide, Xylitol, Stevioside, Camellia Sinensis Leaf Extract, Sodium Methyl Cocoyl Taurate, Ubidecarenone, Cnidium Extract, Menthol, Mint Flavor (Fragrance), Chamomilla Recutita (Matricaria) Flower Extract, Peppermint Flavor (fragrance), D.I-WATER

  • O'PRECARE TOOTHPASTE 3SET (07,12,21)

    oprecare toothpaste 3set

  • INGREDIENTS AND APPEARANCE
    OPRECARE 3SET (07,12,21) 
    sodium monofluorophosphate, silicon dioxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71764-104
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71764-104-011 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package10/12/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PUMP 60 g
    Part 21 BOTTLE, PUMP 60 g
    Part 31 BOTTLE, PUMP 60 g
    Part 1 of 3
    OPRECARE 07 
    sodium monofluorophosphate paste
    Product Information
    Item Code (Source)NDC:71764-100
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.36 g  in 60 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    XYLITOL (UNII: VCQ006KQ1E)  
    MENTHOL (UNII: L7T10EIP3A)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STEVIOSIDE (UNII: 0YON5MXJ9P)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71764-100-021 in 1 PACKAGE
    1NDC:71764-100-0160 g in 1 BOTTLE, PUMP; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/12/2017
    Part 2 of 3
    OPRECARE 12 
    silicon dioxide gel
    Product Information
    Item Code (Source)NDC:71764-101
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE1.71 g  in 60 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    STEVIOSIDE (UNII: 0YON5MXJ9P)  
    Xylitol (UNII: VCQ006KQ1E)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    Calcium Carbonate (UNII: H0G9379FGK)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CHAMOMILE (UNII: FGL3685T2X)  
    SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    Menthol (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71764-101-021 in 1 PACKAGE
    1NDC:71764-101-0160 g in 1 BOTTLE, PUMP; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/12/2017
    Part 3 of 3
    OPRECARE 21 
    sodium monofluorophosphate gel
    Product Information
    Item Code (Source)NDC:71764-102
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.36 g  in 60 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    Xylitol (UNII: VCQ006KQ1E)  
    Stevioside (UNII: 0YON5MXJ9P)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    Menthol (UNII: L7T10EIP3A)  
    LICORICE (UNII: 61ZBX54883)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    Allantoin (UNII: 344S277G0Z)  
    PIRIDOCAINE HYDROCHLORIDE (UNII: VG6P406YHV)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Lemon Oil (UNII: I9GRO824LL)  
    Orange Oil (UNII: AKN3KSD11B)  
    Eucalyptus Oil (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71764-102-021 in 1 PACKAGE
    1NDC:71764-102-0160 g in 1 BOTTLE, PUMP; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/12/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/12/2017
    Labeler - O'PRECARE (694604592)
    Registrant - O'PRECARE (694604592)
    Establishment
    NameAddressID/FEIBusiness Operations
    O'PRECARE694604592relabel(71764-104)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689512611manufacture(71764-104)
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