Label: DENTAL CLINIC 2080 CAVITY PROTECTION- sodium monofluorophosphate paste

  • NDC Code(s): 67225-0001-1
  • Packager: Aekyung Ind. Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 12/12

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  • WARNINGS

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

    Keep out of reach of children under 6 years of age

    Sodium monofluorophosphate 0.75% (0.13% w/v Fluoride ion)

    Sodium carboxymethylcellulose, Sodium lauryl sulfate, Sodium saccharin, Sorbitol, Titanium dioxide, Tocopheryl acetate, water

    Purpose Anticavity

    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 doctor.

    Instruct children under 6 years of age in good brushing ad rinsing habits (to minimize swallowing).

    Supervise children as necessary until capable of using without supervision.

    Children under 2 years of age

    Consult a dentist or doctor

    Aids in the prevention of dental cavities

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  • INGREDIENTS AND APPEARANCE
    DENTAL CLINIC 2080 CAVITY PROTECTION 
    sodium monofluorophosphate paste
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67225-0001
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION 0.156 g  in 120 g
    Inactive Ingredients
    Ingredient Name Strength
    SORBITOL 69.6 g  in 120 g
    SODIUM LAURYL SULFATE 2.64 g  in 120 g
    CARBOXYMETHYLCELLULOSE SODIUM 0.48 g  in 120 g
    TITANIUM DIOXIDE 0.3 g  in 120 g
    SACCHARIN SODIUM 0.156 g  in 120 g
    ALPHA-TOCOPHEROL ACETATE 0.3 g  in 120 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67225-0001-1 120 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 12/01/2012
    Labeler - Aekyung Ind. Co., Ltd. (687995647)
    Establishment
    Name Address ID/FEI Business Operations
    Aekyung Ind. Co., Ltd. 687995647 manufacture(67225-0001)
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