Label: LINHART- sodium fluoride toothpaste paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 70926-100-34, 70926-100-64 - Packager: Linhart 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 March 22, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Fact
- Active ingredient
- Purpose
- Uses
- Warnings
- Keep out of the reach of children under 6 years of age.
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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 doctor.
- Instruct children 6 years of age in good brushing and rinsing habits (to minimize swallowing), and and only use a pea size amount.
- Supervise children as necessary until capable of using without supervision.
- Chlidren under 2 years of age: Consult a dentist or doctor.
- Inactive ingredients
- Principal Primary Panel - Carton 3.5oz
- Principal Primary Panel - Tube 3.5oz
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INGREDIENTS AND APPEARANCE
LINHART
sodium fluoride toothpaste paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70926-100 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 2.5 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) XYLITOL (UNII: VCQ006KQ1E) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALLANTOIN (UNII: 344S277G0Z) SACCHARIN SODIUM (UNII: SB8ZUX40TY) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) THEOBROMINE (UNII: OBD445WZ5P) 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:70926-100-64 1 in 1 CARTON 08/17/2017 1 99 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:70926-100-34 1 in 1 CARTON 08/17/2017 2 28 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 08/17/2017 Labeler - Linhart Inc (080343587)
