Label: PERIOE MICROBIOME TOTAL CARE STRONG MINT- sodium fluoride paste, dentifrice
- NDC Code(s): 43136-820-01
- Packager: Tai Guk Pharm. Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 April 1, 2022
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- Drug Facts
- Active Ingredient
- Purpose
- Use
- Warnings
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Directions
Adults and children 2 years of age and and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist. Do not swallow. To minimize swallowing use a pea-sized amount in children under 6. Supervise children's brushing until good habits are established. Children under 2 years: ask a dentist.
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Inactive Ingredients
WATER, SORBITOL, HYDRATED SILICA, SODIUM LAURYL SULFATE, GLYCERIN, FLAVOR, CELLULOSE GUM, TETRASODIUM PYROPHOSPHATE, XANTHAN GUM, TITANIUM DIOXIDE, SORBITAN OLEATE, SODIUM SACCHARIN, CHARCOAL POWDER, BIFIDA FERMENT EXTRACT FILTRATE, SODIUM CHLORIDE, CANNABIS SATINA SEED OIL, PROPOLIS EXTRACT, TOCOPHERYL ACETATE, XYLITOL
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- Principal Display Panel - 153 g Tube Carton
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INGREDIENTS AND APPEARANCE
PERIOE MICROBIOME TOTAL CARE STRONG MINT
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43136-820 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.4 mg in 1 g Inactive Ingredients Ingredient Name Strength HYDRATED SILICA (UNII: Y6O7T4G8P9) PROPOLIS WAX (UNII: 6Y8XYV2NOF) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM LAURYL SULFATE (UNII: 368GB5141J) XYLITOL (UNII: VCQ006KQ1E) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED) SODIUM CHLORIDE (UNII: 451W47IQ8X) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) XANTHAN GUM (UNII: TTV12P4NEE) MICA (UNII: V8A1AW0880) ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) Product Characteristics Color white Score Shape Size Flavor MINT (Strong) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43136-820-01 1 in 1 CARTON 04/01/2022 1 153 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 OTC monograph final part355 04/01/2022 Labeler - Tai Guk Pharm. Co., Ltd. (689060246) Establishment Name Address ID/FEI Business Operations Tai Guk Pharma. Co., Ltd. 689060246 manufacture(43136-820)