Label: PERIOE POP SENSITIVITY CARE PREBIOTIC CLEAN MINT- stannous fluoride paste, dentifrice
- NDC Code(s): 43136-601-01
- 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
- Purposes
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Uses
- aids in the prevention of cavities
- helps prevent gingivitis
- helps interfere with the harmful effects of plaque associated with gingivitis
- helps control plaque bacteria that contribute to the develpment of gingivitis
- builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
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Warnings
Warnings
When using this product
When using this product do not use for sensitivity longer than four weeks unless recommended by a dentist.
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Directions
- adults and children 12 years & older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.
- do not swallow
- children under 12 years: ask a dentist.
- Other information
- Inactive Ingredients
- Questions?
- Distributed by
- Principal Display Panel - 120 g Tube Carton
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INGREDIENTS AND APPEARANCE
PERIOE POP SENSITIVITY CARE PREBIOTIC CLEAN MINT
stannous fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43136-601 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.4 mg in 1 g Inactive Ingredients Ingredient Name Strength SUCRALOSE (UNII: 96K6UQ3ZD4) HYDRATED SILICA (UNII: Y6O7T4G8P9) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) SODIUM GLUCONATE (UNII: R6Q3791S76) CARRAGEENAN (UNII: 5C69YCD2YJ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) XYLITOL (UNII: VCQ006KQ1E) SACCHARIN SODIUM (UNII: SB8ZUX40TY) STANNOUS CHLORIDE (UNII: 1BQV3749L5) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ZINC CITRATE (UNII: K72I3DEX9B) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM HYDROXIDE (UNII: 55X04QC32I) XANTHAN GUM (UNII: TTV12P4NEE) ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) Product Characteristics Color white Score Shape Size Flavor MINT (Clean) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43136-601-01 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(43136-601)