ROOTSALLO TOOTHPASTE- calcium carbonate, alcloxa, aminocaproic acid, dibasic calcium phosphate dihydrate gel, dentifrice 
rootsallo Qwell

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.

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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

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)

Revised: 12/2021
Document Id: d2472689-fc65-4b47-9f19-dc476af733ab
Set id: 7daf7905-f045-450a-a672-20f17f54b6e0
Version: 1
Effective Time: 20211230
 
rootsallo Qwell