Label: SIMPLY WHITE SWEET MINT- sodium fluoride paste, dentifrice
- NDC Code(s): 51009-149-06
- 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.
Updated September 19, 2023
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- SPL UNCLASSIFIED SECTION
- Active ingredient
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
- PRINCIPAL DISPLAY PANEL - 133.2g Tube Carton
INGREDIENTS AND APPEARANCE
SIMPLY WHITE SWEET MINT
sodium fluoride paste, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51009-149 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.0024 g in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERIN (UNII: PDC6A3C0OX) XYLITOL (UNII: VCQ006KQ1E) SODIUM LAURYL SULFATE (UNII: 368GB5141J) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) XANTHAN GUM (UNII: TTV12P4NEE) PEPPERMINT OIL (UNII: AV092KU4JH) CARRAGEENAN (UNII: 5C69YCD2YJ) ANISE (UNII: 21C2F5E8RE) VANILLIN (UNII: CHI530446X) CLOVE OIL (UNII: 578389D6D0) ZINGERONE (UNII: 4MMW850892) PIPERONAL (UNII: KE109YAK00) Product Characteristics Color Score Shape Size Flavor MINT (Sweet Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51009-149-06 1 in 1 CARTON 03/12/2010 12/30/2025 1 133.2 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 03/12/2010 12/30/2025 Labeler - Tom's of Maine, Inc. (052764354)