Label: PERIOE POP ADVANCED WHITENING PREBIOTIC COOL MINT- sodium fluoride paste, dentifrice
- NDC Code(s): 43136-602-01
- 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 February 17, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Use
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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Directions
- adults and children 2 years of age 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
GLYCERIN, HYDRATED SILICA, SODIUM HEXAMETAPHOSPHATE, WATER, PEG-6, FLAVOR, TRISODIUM PHOSPHATE, SODIUM LAURYL SULFATE, CARRAGEENAN, COCAMIDOPROPYL BETAINE, SODIUM SACCHARIN, SUCRALOSE, XANTHAN GUM, TITANIUM DIOXIDE, MICA, CHARCOAL POWDER, SODIUM CHLORIDE, CITRUS LIMON (LEMON) FRUIT ETRACT, XYLITOL, BIFIDA FERMENT EXTRACT FILTRATE
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INGREDIENTS AND APPEARANCE
PERIOE POP ADVANCED WHITENING PREBIOTIC COOL MINT
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43136-602 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 MICA (UNII: V8A1AW0880) SUCRALOSE (UNII: 96K6UQ3ZD4) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) CARRAGEENAN (UNII: 5C69YCD2YJ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) XYLITOL (UNII: VCQ006KQ1E) SACCHARIN SODIUM (UNII: SB8ZUX40TY) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ZINC CITRATE (UNII: K72I3DEX9B) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM HYDROXIDE (UNII: 55X04QC32I) XANTHAN GUM (UNII: TTV12P4NEE) ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) LEMON (UNII: 24RS0A988O) Product Characteristics Color white Score Shape Size Flavor MINT (Cool) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43136-602-01 1 in 1 CARTON 02/17/2023 1 120 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 02/17/2023 Labeler - Tai Guk Pharm. Co., Ltd. (689060246) Registrant - LG H&H Co., Ltd. (688276187) Establishment Name Address ID/FEI Business Operations Tai Guk Pharma. Co., Ltd. 689060246 manufacture(43136-602)