Label: MINTBLAST ANTI CAVITY FLUORIDE- sodium fluoride paste
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Contains inactivated NDC Code(s)
NDC Code(s): 51289-300-01, 51289-300-02, 51289-300-03, 51289-300-04 - Packager: Yangzhou Hengyuan Daily Chemical Plastic Co.,Ltd
- Category: HUMAN OTC DRUG LABEL
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 15, 2016
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- Active ingredients
- Uses
- Warnings
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Directions
Adults and children 2years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician.
Children 2-6 years:Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
Children under 2 years:Ask a dentist or a physician.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MINTBLAST ANTI CAVITY FLUORIDE
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51289-300 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.243 g in 100 g Inactive Ingredients Ingredient Name Strength DISODIUM CARBOXYMETHYLARSONATE (UNII: T9HTL93NB7) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) XANTHAN GUM (UNII: TTV12P4NEE) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) SODIUM SILICATE (UNII: IJF18F77L3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51289-300-01 144 in 1 BOX 04/15/2016 1 9.9 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:51289-300-02 72 in 1 BOX 04/15/2016 2 9.9 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:51289-300-03 144 in 1 BOX 03/07/2016 3 28.35 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:51289-300-04 72 in 1 BOX 03/07/2016 4 28.35 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 not final part356 03/07/2016 Labeler - Yangzhou Hengyuan Daily Chemical Plastic Co.,Ltd (527127383) Registrant - Yangzhou Hengyuan Daily Chemical Plastic Co.,Ltd (527127383) Establishment Name Address ID/FEI Business Operations Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd. 527127383 manufacture(51289-300)