Label: PERIOE WHITENING ESSENTIALS 10X CHARCOAL BLACK CLEAN MINT- sodium fluoride paste, dentifrice
- NDC Code(s): 43136-803-02
- 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 November 17, 2020
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- Drug Facts
- Active Ingredient
- Purpose
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- Warnings
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Directions
Adults and children 6 years and older Brush teeth thoroughly after each means or at least twice a day, or as directed by a dentist and physician. Do not swallow. Children between 6 and 12 years To minimize swallowing, use a pea-sized amount and supervise children's brushing and rinsing until good habits are established. Children under 6 years Ask a dentist or physician. - Inactive Ingredients
- QUESTIONS
- Principal Display Panel - 20 g Tube
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INGREDIENTS AND APPEARANCE
PERIOE WHITENING ESSENTIALS 10X CHARCOAL BLACK CLEAN MINT
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43136-803 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.6 mg in 1 g Inactive Ingredients Ingredient Name Strength HEXASODIUM HEXAMETAPHOSPHATE (UNII: N40N91DW96) CARRAGEENAN (UNII: 5C69YCD2YJ) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCRALOSE (UNII: 96K6UQ3ZD4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED) SODIUM CHLORIDE (UNII: 451W47IQ8X) HYDRATED SILICA (UNII: Y6O7T4G8P9) XANTHAN GUM (UNII: TTV12P4NEE) MICA (UNII: V8A1AW0880) ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color black Score Shape Size Flavor MINT (Clean) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43136-803-02 1 in 1 TUBE 11/20/2020 1 20 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 11/20/2020 Labeler - Tai Guk Pharm. Co., Ltd. (689060246) Establishment Name Address ID/FEI Business Operations Tai Guk Pharma. Co., Ltd. 689060246 manufacture(43136-803)