Label: MEIJER BRILLIANT WHITE- sodium fluoride paste, dentifrice
- NDC Code(s): 41250-200-02, 41250-200-09
- Packager: Meijer
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredients / Purpose
Sodium fluoride 0.243% ............AnticavityClose
- aids in the prevention of dental cavities
Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Adults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to avoid swallowing). Supervise children as necessary until capable of using without supervision.Close
- DOSAGE & ADMINISTRATION
Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: consult a dentist or a doctor.Close
- Other Information
Store in a cool dry place. Keep tube capped when not in use.Close
- Inactive ingredients
water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, xanthan gum, carbomer, sodium saccharin, sodium hydroxide, mica, titanium dioxide, blue 1 lake, polyethyleneClose
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
MEIJER BRILLIANT WHITE
fluoride paste, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-200 Route of Administration DENTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.243 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM HYDROXIDE (UNII: 55X04QC32I) XANTHAN GUM (UNII: TTV12P4NEE) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) SODIUM LAURYL SULFATE (UNII: 368GB5141J) MICA (UNII: V8A1AW0880) Product Characteristics Color blue (light blue with sparkles) Score Shape Size Flavor MINT (mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-200-09 1 in 1 CARTON 1 NDC:41250-200-02 164 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/20/2011 Labeler - Meijer (006959555) Registrant - Lornamead (126440440) Establishment Name Address ID/FEI Business Operations Lornamead 126440440 manufacture(41250-200) , pack(41250-200)