Label: FRAICHE KIDS PASTE, BUBBLE GUM FLAVOR- sodium fluoride paste
- NDC Code(s): 83592-803-46
- Packager: True Marker Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 27, 2024
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- Active Ingredient
- Purpose
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Warnings
Keep out of reach of children under 6 years of age. If more than the recommended amount of the paste used for brushing is
accidentally swallowed, get medical help or contact the Poison Control Center right away. In case of an allergic reaction, stop use, rinse mouth with water and seek medical advice. - KEEP OUT OF REACH OF CHILDREN
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Directions
For adults and children 2 years of age or older, apply a small peasized amount of FRAICHE Kids dental gel to your toothbrush. For best results,
brush for 2 minutes, expectorate and avoid eating or drinking for 30 minutes after brushing. Use twice daily. Replace cap after use.
For children under 2 years of age, consult a dentist or physician.
- Other information
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INGREDIENTS AND APPEARANCE
FRAICHE KIDS PASTE, BUBBLE GUM FLAVOR
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83592-803 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.24 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) XYLITOL (UNII: VCQ006KQ1E) PHOSPHORIC ACID (UNII: E4GA8884NN) SACCHARIN SODIUM (UNII: SB8ZUX40TY) ETHYLPARABEN POTASSIUM (UNII: 528JBB2994) BUTYL SALICYLATE (UNII: QPR9LM8VZO) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83592-803-46 1 in 1 BOX 06/20/2024 1 46 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 Drug M021 06/20/2024 Labeler - True Marker Pharmaceuticals, Inc. (119046582)