Label: FINEFRA AID TOOTH- precipitated calcium carbonate, tocopherol acetate, aluminum chlorohydroxy allantoinate, dibasic calcium phosphate hydrate paste, dentifrice

  • NDC Code(s): 69653-130-01, 69653-130-02, 69653-130-03
  • Packager: Jewoo Medical Co,.Ltd
  • 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 June 3, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    Precipitated Calcium Carbonate 0.10%
    Tocopherol Acetate 0.04%
    Aluminum Chlorohydroxy Allantoinate 0.04%
    Dibasic Calcium Phosphate Hydrate 0.04%

  • INACTIVE INGREDIENTS

    D-Sorbitol Solution, Purified Water in Bulk, Glycerin, Silica, Sodium Cocoyl Glutamate, Mica, Peppermint Flavor, Active Carbon, Steviol Glycoside, Carboxymethylcellulose Sodium, Chitosan, Xylitol, Grapefruit Seed Extract, Anethole, L-Menthol, Propolis Extract, Scutellaria Root Extract, Sophora Extract, Aloe Extract(09), Gentian Extract, Lavender Extract(1), Rosemary Extract, Mastic Oil, Chamaecyparis Obtusa Oil, Eucalyptus Oil, Glycyrrhiza Extract, Sage Extract, Argentum

  • PURPOSE

    Anticavity

  • WARNINGS

    Keep out of the reach of children under 6 years of age.

    If you accidentally swallow more than used for brushing, Seek professional help or contact a poison control center immediately

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children under 6 years of age.

  • Uses

    Uses:

    Aids in the prevention of cavities, plaque, and gingivitis.

  • Directions

    Directions:

    Adults and children 2 yrs. older: Brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician. Do not swallow. Children under 6 yrs.: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. Children under 2 yrs.: Ask a dentist or physician.

  • Package Label: Finefra Aid Toothpaste 20g

    Image of tube

  • Package Label: Finefra Aid Toothpaste 100g

    Image of carton

  • Package Label: Finefra Aid Toothpaste 135g

    Image of carton

  • INGREDIENTS AND APPEARANCE
    FINEFRA AID TOOTH 
    precipitated calcium carbonate, tocopherol acetate, aluminum chlorohydroxy allantoinate, dibasic calcium phosphate hydrate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69653-130
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION0.10 g  in 100 g
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE0.04 g  in 100 g
    ALCLOXA (UNII: 18B8O9DQA2) (ALLANTOIN - UNII:344S277G0Z) ALCLOXA0.04 g  in 100 g
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J) DIBASIC CALCIUM PHOSPHATE DIHYDRATE0.04 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69653-130-0120 g in 1 TUBE; Type 0: Not a Combination Product05/01/2020
    2NDC:69653-130-02100 g in 1 CARTON; Type 0: Not a Combination Product05/01/2020
    3NDC:69653-130-03135 g in 1 CARTON; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2020
    Labeler - Jewoo Medical Co,.Ltd (689512541)
    Registrant - Jewoo Medical Co,.Ltd (689512541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woorilife&Health694860803manufacture(69653-130)