Label: RITE AID BRILLIANT WHITE- sodium monoflourophosphate paste, dentifrice
- NDC Code(s): 11822-6032-8
- Packager: Rite Aid
- 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 January 11, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
Adults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice per day, or as directed by a dentist or doctor.
- Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
- Supervise children as necessary until capable of using without supervision.
- Children under 2 years of age: consult a dentist or doctor.
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RITE AID BRILLIANT WHITE
sodium monoflourophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-6032 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.76 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCRALOSE (UNII: 96K6UQ3ZD4) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0) PHOSPHORIC ACID (UNII: E4GA8884NN) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM LAURYL SULFATE (UNII: 368GB5141J) ETIDRONIC ACID (UNII: M2F465ROXU) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) WATER (UNII: 059QF0KO0R) HYDROGEN PEROXIDE (UNII: BBX060AN9V) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-6032-8 1 in 1 CARTON 03/03/2019 1 113 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 03/03/2019 Labeler - Rite Aid (014578892) Registrant - Lornamead Inc. (080046418) Establishment Name Address ID/FEI Business Operations Lornamead Inc. 080046418 manufacture(11822-6032)