Label: RITE AID PRO DEFENSE WHITENING- stannous fluoride paste, dentifrice
- NDC Code(s): 11822-6034-9
- Packager: Rite Aid
- Category: HUMAN OTC DRUG LABEL
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 thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day or as day or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing
- To minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing until good habits are established
- Children under 2 years of age: consult a dentist or doctor.
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STORAGE AND HANDLING
Other information
- products containing stannous fluoride may cause surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed your dentist.
- This product is specifically formulated to help prevent staining
- store below 77°F (25°C)
- Keep tube capped when not in use.
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RITE AID PRO DEFENSE WHITENING
stannous fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-6034 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.454 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM LAURYL SULFATE (UNII: 368GB5141J) GLYCERIN (UNII: PDC6A3C0OX) HYDRATED SILICA (UNII: Y6O7T4G8P9) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) Product Characteristics Color white Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-6034-9 1 in 1 CARTON 03/03/2019 1 96.4 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 not final part356 03/03/2019 Labeler - Rite Aid (014578892) Registrant - Lornamead Inc. (080046418) Establishment Name Address ID/FEI Business Operations Lornamead Inc. 080046418 manufacture(11822-6034)