Label: PLUS WHITE XTRA- sodium monofluorophosphate paste
- NDC Code(s): 61543-7237-3
- Packager: CCA Industries, Inc.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated August 13, 2021
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- Drug Facts
- Active ingredient
- 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
- to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing until good habits are established
- children under 2 years ask a dentist or physician
- Inactive ingredients
- Questions or comments?
- Package Labeling:
INGREDIENTS AND APPEARANCE
PLUS WHITE XTRA
sodium monofluorophosphate paste
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61543-7237 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.1 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM PHOSPHATE (UNII: SE337SVY37) SACCHARIN SODIUM (UNII: SB8ZUX40TY) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61543-7237-3 1 in 1 BOX 03/15/2019 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 06/11/2010 Labeler - CCA Industries, Inc. (106771041)