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.
Updated July 23, 2018
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- ACTIVE INGREDIENT
Active ingredients: CALCIUM CARBONATE 40%, 6-AMINOCAPROIC ACID 0.01%Close
- INACTIVE INGREDIENT
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, AQUAClose
[PERIODONTAL, GINGIVITIS (GUM) DISEASE PREVENTION]Close
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 immediatelyClose
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children under 6 years of age.Close
■ Refreshes and whitens teeth by daily use. Helps to prevent plague and gingivitisClose
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.Close
- 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)