Label: GLISTER MULTI-ACTION- sodium fluoride paste, dentifrice
- NDC Code(s): 10056-415-00, 10056-415-01
- Packager: Access Business Group LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 23, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Use
- Warnings
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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 under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
Supervise children as necessary until capable of using without supervision.
• Children under 2 years of age: Consult a dentist or doctor.
- Inactive Ingredients
- Package Labeling:50g
- Package Labeling:200g
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INGREDIENTS AND APPEARANCE
GLISTER MULTI-ACTION
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10056-415 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 2.1 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) XYLITOL (UNII: VCQ006KQ1E) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM BENZOATE (UNII: OJ245FE5EU) XANTHAN GUM (UNII: TTV12P4NEE) SACCHARIN SODIUM (UNII: SB8ZUX40TY) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10056-415-00 1 in 1 CARTON 03/22/2023 1 50 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10056-415-01 1 in 1 CARTON 03/22/2023 2 200 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 03/22/2023 Labeler - Access Business Group LLC (839830713)