SALTRAIN TOOTH- sodium monofluorophosphate, precipitated calcium carbonate, dibasic calcium phosphate, aminocaproic acid, aluminium chlorohydroxy allantoinate paste, dentifrice
K.Boeun Pharmaceutical 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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Sodium Monofluorophosphate, Precipitated Calcium Carbonate, Dibasic Calcium Phosphate, Aminocaproic Acid, Aluminium Chlorohydroxy Allantoinate

D-Sorbitol Solution
Concentrated Glycerin
Polyethylene Glycol 1500
Xanthangum
Sodium Cocoyl Glutamate
Silicon Dioxide
Titanium Oxide
Enzymatically Modified Stevia

Xylitol
Sodium Chloride

Ascorbic Acid
Mentha Oil

l-Menthol
Spearmint Oil
Water

For dental care

Keep out of reach of children

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

Warnings

Keep out of reach of children

■ If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Other Information

■ Store in an airtight container at room temperature

■ Date of use : 36 months from the date of manufacture

For dental use only

SALTRAIN TOOTH
sodium monofluorophosphate, precipitated calcium carbonate, dibasic calcium phosphate, aminocaproic acid, aluminium chlorohydroxy allantoinate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74724-0025
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.4 g in 100 g
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) (CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS - UNII:L11K75P92J)	CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	0.07 g in 100 g
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	36 g in 100 g
ALCLOXA (UNII: 18B8O9DQA2) (ALCLOXA - UNII:18B8O9DQA2)	ALCLOXA	0.06 g in 100 g
AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206)	AMINOCAPROIC ACID	0.06 g in 100 g

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74724-0025-1	30 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		05/01/2021

Labeler - K.Boeun Pharmaceutical Co.,Ltd. (695674074)

Registrant - K.Boeun Pharmaceutical Co.,Ltd. (695674074)

Name	Address	ID/FEI	Business Operations
Establishment
K.Boeun Pharmaceutical Co.,Ltd.		695674074	manufacture(74724-0025)