RELIEF AND NATURE TOOTHPAST E JASMINE MINT by NATURE REPUBLIC CO., LTD. / Kolmar Korea Co., Ltd.

Drug Details [pdf]

RELIEF AND NATURE TOOTHPAST E JASMINE MINT- calcium carbonate, aminocaproic acid paste, dentifrice
NATURE REPUBLIC 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.

----------

ACTIVE INGREDIENT

Active ingredients: CALCIUM CARBONATE 40%, 6-AMINOCAPROIC ACID 0.01%

INACTIVE INGREDIENT

Inactive ingredients:

O-TOLUENESULFONAMIDE, SODIUM HYDROXIDE, SULFURIC ACID, CARBOXYMETHYLCELLULOSE SODIUM, TITANIUM DIOXIDE, AQUA, CAMELLIA SINENSIS LEAF EXTRACT, ALCOHOL, BUTYLENE GLYCOL, EUCALYPTUS OIL, MENTHOL, MENTHA VIRIDIS (SPEARMINT) LEAF OIL, ANETHOLE, EUCALYPTOL, MENTHA PIPERITA (PEPPERMINT) OIL, PROPYLENE GLYCOL, L-MENTHONE, L-MENTHYL ACETATE, L-CARBON, LIMONENE, PINENE, PROPYLENE GLYCOL, MENTHOL, MENTHA PIPERITA (PEPPERMINT) OIL, ALCOHOL, PHENETHYL ALCOHOL, ANETHOLE, HEXYL CINNAMAL, BENZYL ACETATE, MENTHA VIRIDIS (SPEARMINT) LEAF OIL, EUCALYPTUS OIL, LINALOOL, METHYL ANTHRANILATE, LIMONENE, EUGENOL, CINNAMAL, HELIOTROPINE, LAUROYL AMIDOPROPYL DIMETHYL GLYCINE SOLUTION, ALUMINIUM HYDROXIDE CHLORIDE, ALLANTOIN, CACO3, CAOH, SODIUM COCOYL GLUTAMATE, SORBITOL, MALTITOL, SILICON, ETHYLENE OXIDE (SYNTHETIC), POLYETHYLENE GLYCOL (600), MENTHOL, XYLITOL, SODIUM CARBONATE, MEDICINAL CARBON, AQUA

PURPOSE

Purpose:

[ANTI PLAGUE]

[PERIODONTAL, GINGIVITIS (GUM) DISEASE PREVENTION]

WARNINGS

Warnings:

Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center immediately

KEEP OUT OF REACH OF CHILDREN

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

Uses

Uses:

■ Refreshes and whitens teeth by daily use. Helps to prevent plague and gingivitis

Directions

Directions:

Adults and children 12 years of age and older :

■ apply at least 1 inch strip of product onto a soft bristle toothbrush

■ brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.

Children under 12 years of age : consult a dentist or doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

RELIEF AND NATURE TOOTHPAST E JASMINE MINT
calcium carbonate, aminocaproic acid paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-508
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	60.0 g in 150 g
AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206)	AMINOCAPROIC ACID	0.015 g in 150 g

Ingredient Name	Strength
Inactive Ingredients
O-TOLUENESULFONAMIDE (UNII: R81Z6V889P)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 51346-508-02	1 in 1 CARTON	07/01/2018	11/01/2019
1	NDC: 51346-508-01	150 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		07/01/2018	11/01/2019

Labeler - NATURE REPUBLIC CO., LTD. (631172020)

Registrant - NATURE REPUBLIC CO., LTD. (631172020)

Name	Address	ID/FEI	Business Operations
Establishment
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(51346-508)

Revised: 12/2019

Document Id: 46ca1cac-9dd1-498d-a3d0-2d961bd72b55

Set id: d2b0c1dc-d1de-4e5e-91ed-8defbd1cf47e

Version: 2

Effective Time: 20191231