| NDC | 53208-459-01, 53208-459-02 |
| Set ID | c1806a01-c687-4815-a7e5-c875e9b8e255 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | LG Household and Healthcare, Inc. |
| Generic Name | |
| Product Class | Antifibrinolytic Agent |
| Product Number | |
| Application Number | PART355 |
- ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- WARNINGS AND PRECAUTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BAMBOO SALT EUNGANGGO JOOK YEOM TOOTHPASTE
silicon dioxide , sodium fluoride, aminocaproic acid, glycyrrhizinate dipotassium, curcuma xanthorrhiza oil, sea salt pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53208-459 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 20 g in 100 g SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) SODIUM FLUORIDE 0.22 g in 100 g AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) AMINOCAPROIC ACID 0.05 g in 100 g GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) (GLYCYRRHIZINATE DIPOTASSIUM - UNII:CA2Y0FE3FX) GLYCYRRHIZINATE DIPOTASSIUM 0.04 g in 100 g URSODIOL (UNII: 724L30Y2QR) (URSODIOL - UNII:724L30Y2QR) URSODIOL 0.02 g in 100 g Curcuma xanthorrhiza oil (UNII: F8VF0V2G7H) (Curcuma xanthorrhiza oil - UNII:F8VF0V2G7H) Curcuma xanthorrhiza oil 0.025 g in 100 g SEA SALT (UNII: 87GE52P74G) (SEA SALT - UNII:87GE52P74G) SEA SALT 3 g in 100 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) Polyethylene Glycol 300 (UNII: 5655G9Y8AQ) XANTHAN GUM (UNII: TTV12P4NEE) Poloxamer 407 (UNII: TUF2IVW3M2) Sodium Lauryl Sulfate (UNII: 368GB5141J) Sodium Bisulfite (UNII: TZX5469Z6I) Titanium Dioxide (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Peppermint (UNII: V95R5KMY2B) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) METHYLPARABEN (UNII: A2I8C7HI9T) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53208-459-02 1 in 1 CARTON 1 NDC:53208-459-01 170 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part355 05/25/2010 Labeler - LG Household and Healthcare, Inc. (688276187) Registrant - LG Household and Healthcare, Inc. (688276187) Establishment Name Address ID/FEI Business Operations LG Household and Healthcare, Inc. 688276187 manufacture
