Label: DINOSAUR- sodium fluoride paste
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Contains inactivated NDC Code(s)
NDC Code(s): 71775-070-52, 71775-070-53, 71775-070-54, 71775-070-55 - Packager: LMZ
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 May 1, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Use
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- Do Not Use
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Directions
Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
- Do not swallow.
- To minimize swallowing use a pea sized amount in children under 6 years.
- Supervise children’s brushing until good habits are established.
- Children under 2 years of age, consult a dentist or physician.
- Inactive Ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DINOSAUR
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71775-070 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 100 mg in 100 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) SODIUM CHLORIDE (UNII: 451W47IQ8X) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ) SORBITOL (UNII: 506T60A25R) ZANTHOXYLUM NITIDUM ROOT (UNII: L2CQZ81759) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) BENZYL ALCOHOL (UNII: LKG8494WBH) SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O) ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H) CLINOPODIUM CHINENSE WHOLE (UNII: 29350ODC51) CHONDRUS CRISPUS (UNII: OQS23HUA1X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71775-070-54 24 g in 1 TUBE; Type 0: Not a Combination Product 01/22/2021 2 NDC:71775-070-52 120 g in 1 TUBE; Type 0: Not a Combination Product 01/22/2021 3 NDC:71775-070-55 24 g in 1 TUBE; Type 0: Not a Combination Product 04/30/2021 4 NDC:71775-070-53 120 g in 1 TUBE; Type 0: Not a Combination Product 04/30/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/22/2021 Labeler - LMZ (654623156) Establishment Name Address ID/FEI Business Operations LMZ 654623156 manufacture(71775-070)
