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

ROOTSALLO TOOTHPASTE by

Drug Labeling and Warnings

ROOTSALLO TOOTHPASTE by is a Otc medication manufactured, distributed, or labeled by rootsallo Qwell, Woorilife&Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82450-050
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	10.30 g  in 100 g
ALCLOXA (UNII: 18B8O9DQA2) (ALLANTOIN - UNII:344S277G0Z)	ALCLOXA	0.05 g  in 100 g
Aminocaproic Acid (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206)	Aminocaproic Acid	0.05 g  in 100 g
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J)	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	0.30 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
Glycerin (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82450-050-02	1 in 1 CARTON	12/01/2021
1	NDC: 82450-050-01	120 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/01/2021

Labeler - rootsallo Qwell (695495466)

Registrant - rootsallo Qwell (695495466)

Establishment
Name	Address	ID/FEI	Business Operations
Woorilife&Health		694860803	manufacture(82450-050)