Label: SEA SALT ANTICAVITY SALT47 GENTLY SCRUBS AWAY SURFACE STAINS / FIGHTS BAD BREATH GERMS / STRENGTHENS ENAMEL- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 51009-901-47 - Packager: Toms 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 August 30, 2019
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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 - 133 g Tube Carton
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INGREDIENTS AND APPEARANCE
SEA SALT ANTICAVITY SALT47 GENTLY SCRUBS AWAY SURFACE STAINS / FIGHTS BAD BREATH GERMS / STRENGTHENS ENAMEL
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51009-901 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 0.0024 g in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Sorbitol (UNII: 506T60A25R) Hydrated Silica (UNII: Y6O7T4G8P9) Xylitol (UNII: VCQ006KQ1E) Glycerin (UNII: PDC6A3C0OX) Sodium Chloride (UNII: 451W47IQ8X) Sodium Lauryl Sulfate (UNII: 368GB5141J) Zinc Citrate (UNII: K72I3DEX9B) Peppermint Oil (UNII: AV092KU4JH) Xanthan Gum (UNII: TTV12P4NEE) Carrageenan (UNII: 5C69YCD2YJ) Product Characteristics Color WHITE Score Shape Size Flavor PEPPERMINT (Refreshing Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51009-901-47 1 in 1 CARTON 11/12/2018 1 133 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 11/12/2018 Labeler - Toms of Maine, Inc. (052764354) Establishment Name Address ID/FEI Business Operations Toms of Maine, Inc. 829517189 MANUFACTURE(51009-901)