Label: BAMBOO SALT EUNGANGGO JOOK YEOM TOOTHPASTE- silicon dioxide , sodium fluoride, aminocaproic acid, glycyrrhizinate dipotassium, curcuma xanthorrhiza oil, sea salt paste
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Contains inactivated NDC Code(s)
NDC Code(s): 53208-459-01, 53208-459-02 - Packager: LG Household and Healthcare, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 21, 2010
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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
