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

  • NDC Code(s): 51346-508-01, 51346-508-02
  • Packager: NATURE REPUBLIC CO., LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated July 23, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

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

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  • 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

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  • PURPOSE

    Purpose:

    [ANTI PLAGUE]

    [PERIODONTAL, GINGIVITIS (GUM) DISEASE PREVENTION]

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  • 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

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • Uses

    Uses:

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

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  • 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.

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    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
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    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
    Inactive Ingredients
    Ingredient Name Strength
    O-TOLUENESULFONAMIDE (UNII: R81Z6V889P)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51346-508-02 1 in 1 CARTON 07/01/2018
    1 NDC:51346-508-01 150 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 07/01/2018
    Labeler - NATURE REPUBLIC CO., LTD. (631172020)
    Registrant - NATURE REPUBLIC CO., LTD. (631172020)
    Establishment
    Name Address ID/FEI Business Operations
    Kolmar Korea Co., Ltd. 689512611 manufacture(51346-508)
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