Label: ROOTSALLO TOOTHPASTE- calcium carbonate, alcloxa, aminocaproic acid, dibasic calcium phosphate dihydrate gel, dentifrice

  • NDC Code(s): 82450-050-01, 82450-050-02
  • Packager: rootsallo Qwell
  • 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 30, 2021

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

  • ACTIVE INGREDIENTS

    CALCIUM CARBONATE 10.30%
    ALCLOXA 0.05%
    Aminocaproic Acid 0.05%
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE 0.30%

  • PURPOSE

    Anti plaque, Anti cavities, Healthy Gums, Prevent Gingivitis and Perioodontitis, Prevent Periodontal Disease

  • Uses

    Antiplaque, Anticavity, Healthy Gums Toothpaste

  • Warnings

    (1) Do not swallow, gargle fully after using.
    (2) If the use of this paste causes gingiva or oral cavity injury, please stop using and consult a doctor or a dentist.
    (3) If childern under 6 years of age use, please apply a pea-sized amount each thime.
    Do not swallow. Please use under the guidance of the guardian.
    (4) If children under 6 years of age accidentally ingest large amounts of the paste, please consult a doctor or a dentist immediately.
    (5) Keep out of reach of children under 6 years of age.
    (6) This product contains sodium benzoate, which has mild irritation to the skin, eyes and mucosa.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Brushing the teeth with a suitable amount

  • Other Information

    Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light.

  • Questions

    www.rootsallo.com 82-31-429-0588

  • Inactive ingredients

    D-Sorbitol Solution, Glycerin, Silica, Xanthan Gum, Carboxymethylcellulose Sodium, Sodium Lauryl Sulfate, Grapefruit Seed Extract, Saccharin Sodium Hydrate, Xylitol, L-Menthol, Green Tea Extract, Propolis Extract, Chitosan, Phytoncide Flavor, Chamaecyparis Obtusa Oil, Water

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ROOTSALLO TOOTHPASTE 
    calcium carbonate, alcloxa, aminocaproic acid, dibasic calcium phosphate dihydrate gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82450-050
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION10.30 g  in 100 g
    ALCLOXA (UNII: 18B8O9DQA2) (ALLANTOIN - UNII:344S277G0Z) ALCLOXA0.05 g  in 100 g
    Aminocaproic Acid (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) Aminocaproic Acid0.05 g  in 100 g
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J) DIBASIC CALCIUM PHOSPHATE DIHYDRATE0.30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    Glycerin (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82450-050-021 in 1 CARTON12/01/2021
    1NDC:82450-050-01120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/01/2021
    Labeler - rootsallo Qwell (695495466)
    Registrant - rootsallo Qwell (695495466)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woorilife&Health694860803manufacture(82450-050)