Label: POP HINT OF MINT- sodium fluoride paste, dentifrice
- NDC Code(s): 43136-511-20
- 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 September 18, 2023
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- Official Label (Printer Friendly)
- 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.
- Inactive Ingredients
- Questions?
- Principal Display Panel - 120 g Tube Carton
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INGREDIENTS AND APPEARANCE
POP HINT OF MINT
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43136-511 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 SORBITOL (UNII: 506T60A25R) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) NIACINAMIDE (UNII: 25X51I8RD4) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) ZINC STEARATE (UNII: H92E6QA4FV) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) POLOXAMER 407 (UNII: TUF2IVW3M2) SODIUM LAURYL SULFATE (UNII: 368GB5141J) XANTHAN GUM (UNII: TTV12P4NEE) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCRALOSE (UNII: 96K6UQ3ZD4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) XYLITOL (UNII: VCQ006KQ1E) HYDRATED SILICA (UNII: Y6O7T4G8P9) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43136-511-20 1 in 1 CARTON 09/18/2023 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 09/18/2023 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(43136-511)