Label: PLUS WHITE- sodium monofluorophosphate paste, dentifrice
- NDC Code(s): 61543-1751-3
- Packager: CCA Industries, 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 1, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Keep out of the reach of children under 6 years of age.
- Directions
- INACTIVE INGREDIENT
- QUESTIONS
- Principal Display Panel -Tube 2.0 oz
- Principal Display Panel - Carton 2.0 oz
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INGREDIENTS AND APPEARANCE
PLUS WHITE
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61543-1751 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.83 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) CARBOMER 940 (UNII: 4Q93RCW27E) SODIUM CARBONATE (UNII: 45P3261C7T) CALCIUM PEROXIDE (UNII: 7FRO2ENO91) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color white Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61543-1751-3 1 in 1 CARTON 05/22/2018 1 56.6 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 05/22/2018 Labeler - CCA Industries, Inc. (106771041) Registrant - Sheffield Pharmaceuticals LLC (151177797) Establishment Name Address ID/FEI Business Operations Sheffield Pharmaceuticals LLC 151177797 manufacture(61543-1751)
