Label: SILLY STRAWBERRY ANTICAVITY - BFT51 MRT- sodium monofluorophosphate paste, dentifrice
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NDC Code(s):
51009-910-01,
51009-910-10,
51009-910-42,
51009-910-51, view more51009-910-52, 51009-910-53
- Packager: Tom's of Maine, Inc.
- 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 19, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
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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 or physician children 2 to 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 physician - Inactive ingredients
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- PRINCIPAL DISPLAY PANEL - 144 g Tube Label
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INGREDIENTS AND APPEARANCE
SILLY STRAWBERRY ANTICAVITY - BFT51 MRT
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51009-910 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.0014 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CARRAGEENAN (UNII: 5C69YCD2YJ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) HYDRATED SILICA (UNII: Y6O7T4G8P9) BENZYL ALCOHOL (UNII: LKG8494WBH) CALCIUM CARBONATE (UNII: H0G9379FGK) STRAWBERRY (UNII: 4J2TY8Y81V) LEMON JUICE (UNII: AGN709ANTJ) MANGO JUICE (UNII: IU6I1JNV24) ORANGE JUICE (UNII: 5A9KE2L9L3) PINEAPPLE JUICE (UNII: O4KOG0B1KC) STRAWBERRY JUICE (UNII: U8NS58UGW0) Product Characteristics Color WHITE Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51009-910-51 144 g in 1 TUBE; Type 0: Not a Combination Product 11/15/2019 2 NDC:51009-910-10 1 in 1 CARTON 01/14/2013 2 21 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:51009-910-42 119 g in 1 TUBE; Type 0: Not a Combination Product 08/16/2010 4 NDC:51009-910-52 2 in 1 CARTON 11/04/2020 01/29/2023 4 144 g in 1 TUBE; Type 0: Not a Combination Product 5 NDC:51009-910-01 21 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2015 03/30/2020 6 NDC:51009-910-53 3 in 1 CARTON 02/15/2022 03/21/2024 6 150 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 08/15/2010 Labeler - Tom's of Maine, Inc. (052764354) Establishment Name Address ID/FEI Business Operations Team Technologies, Inc 079527756 PACK(51009-910)