Label: PLUS WHITE XTRA- sodium monofluorophosphate paste
- NDC Code(s): 61543-7237-3
- 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 13, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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)