Label: MEIJER DRY MOUTH- sodium fluoride paste, dentifrice
- NDC Code(s): 41250-531-29
- Packager: Meijer Distribution 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 January 11, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
Adults and children 12 years of age and older: Apply onto a soft bristle toothbrush.
- Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician.
Children under 12 years of age: consult a dentist or physician. Once recommended, to minimize swallowing for children under 6,use a pea sized amount and supervise brushing until good habits are established.
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MEIJER DRY MOUTH
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-531 Route of Administration DENTAL 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) SODIUM HYDROXIDE (UNII: 55X04QC32I) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SUCRALOSE (UNII: 96K6UQ3ZD4) HYDRATED SILICA (UNII: Y6O7T4G8P9) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) XANTHAN GUM (UNII: TTV12P4NEE) GLYCERIN (UNII: PDC6A3C0OX) SACCHARIN SODIUM (UNII: SB8ZUX40TY) 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:41250-531-29 1 in 1 CARTON 02/25/2019 1 122 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 02/25/2019 Labeler - Meijer Distribution Inc (006959555) Registrant - Lornamead Inc. (080046418) Establishment Name Address ID/FEI Business Operations Lornamead Inc. 080046418 manufacture(41250-531)