GRAY SALT by DONG IL PHARMS CO.,LTD / DONG IL PHARMS CO., LTD.

GRAY SALT by

Drug Labeling and Warnings

GRAY SALT by is a Otc medication manufactured, distributed, or labeled by DONG IL PHARMS CO.,LTD, DONG IL PHARMS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GRAY SALT- precipitated calcium carbonate, dibasic calcium phosphate, aminocaproic acid, aluminium chlorohydroxy allantoinate paste, dentifrice 
DONG IL PHARMS CO.,LTD

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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Precipitated Calcium Carbonate, Dibasic Calcium Phosphate, Aminocaproic Acid, Aluminium Chlorohydroxy Allantoinate

For dental care

Keep out of reach of children

Apply an appropriate amount to your toothbrush and brush your teeth by brushing.

Storage method

1. Keep it at room temperature in a classified container.

2. Cover and store at room temperature.

3. Store in a not moisture and cool place.

4. Air may come out during use of this product, but there is no problem with its weight.

Usage Precautions

1. Be careful not to swallow. Rinse mouth thoroughly after use

2. If the use of toothpaste causes abnormalities such as gums or mouth injury, discontinue use and consult a doctor or dentist.

3. For children under 6 years of age, use a small amount of toothpaste as small as pea per use, and use under the guidance of a guardian to avoid sucking or swallowing.

4. If a child under 6 years old swallows large amount, consult with a doctor or dentist immediately.

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

Silicon Dioxide, Concentrated Glycerin, D-Sorbitol Solution, Polyethylene Glycol 1500, Carboxymethlycellulose Sodium, Saccharin Sodium Hydrate, Xylitol, Sodium Chloride, L-Menthol, Peppermint Oil, Sodium Lauryl Sulfate, Titanium Oxide, Sodium Benzoate, Ascorbic Acid, Water

For dental use only

GRAY SALT 
precipitated calcium carbonate, dibasic calcium phosphate, aminocaproic acid, aluminium chlorohydroxy allantoinate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73242-0104
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	38 g  in 100 g
ALCLOXA (UNII: 18B8O9DQA2) (ALCLOXA - UNII:18B8O9DQA2)	ALCLOXA	0.05 g  in 100 g
AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206)	AMINOCAPROIC ACID	0.05 g  in 100 g
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) (CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS - UNII:L11K75P92J)	CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	0.06 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73242-0104-1	100 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2020	08/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/01/2020	08/20/2020

Labeler - DONG IL PHARMS CO.,LTD (557810721)

Registrant - DONG IL PHARMS CO.,LTD (557810721)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture(73242-0104)

Revised: 8/2020

Document Id: ad467882-879d-2849-e053-2a95a90a2b09

34390-5

Set id: ad464a8f-953a-cb61-e053-2a95a90a591a

Version: 2

Effective Time: 20200819