Label: BLUE SAVE THE ANIMALS- sodium monofluorophosphate cream
- NDC Code(s): 51009-916-51
- 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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- 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
BLUE SAVE THE ANIMALS
sodium monofluorophosphate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51009-916 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.4 mg in 1 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) CALCIUM CARBONATE (UNII: H0G9379FGK) HYDRATED SILICA (UNII: Y6O7T4G8P9) CARRAGEENAN (UNII: 5C69YCD2YJ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) BENZYL ALCOHOL (UNII: LKG8494WBH) REBAUDIOSIDE A (UNII: B3FUD0528F) Product Characteristics Color WHITE Score Shape Size Flavor BLUEBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51009-916-51 144 g in 1 TUBE; Type 0: Not a Combination Product 06/30/2021 12/30/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 06/30/2021 12/30/2025 Labeler - Tom's of Maine, Inc. (052764354) Registrant - Coglate-Palmolive Company (068693167)