Label: PLUS WHITE EXTRA WHITENING- sodium monofluorophosphate gel, dentifrice
- NDC Code(s): 61543-1606-3
- 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 December 26, 2019
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- Official Label (Printer Friendly)
- Active Ingredient
- Keep out of the reach of children under 6 years of age.
- Adults and children 2 years and older
- Brush teeth thoroughly, after each meal, or at least twice a day, or as directed by a dentist or physician
- instruct under 6 years of age in good brushing and rinse habits (it minimizes swallowing), and only use a pea size amount.
- Children under 2 years ask a dentist or physician
- INACTIVE INGREDIENT
- Principal Display Panel -Tube 3.5 oz
- Principal Display Panel - Carton 3.5 oz
INGREDIENTS AND APPEARANCE
PLUS WHITE EXTRA WHITENING
sodium monofluorophosphate gel, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61543-1606 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) POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) COPOVIDONE K25-31 (UNII: D9C330MD8B) TRISODIUM DIPHOSPHATE (UNII: AR7OGW33N1) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) Product Characteristics Color green Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61543-1606-3 1 in 1 CARTON 01/31/2018 1 100 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 01/31/2018 Labeler - CCA Industries, Inc. (106771041) Registrant - Sheffield Pharmaceuticals LLC (151177797) Establishment Name Address ID/FEI Business Operations Sheffield Pharmaceuticals LLC 151177797 manufacture(61543-1606)