Label: CLARBEN- sodium fluoride gel
- NDC Code(s): 53045-214-17
- Packager: Dharma Research, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated July 2, 2021
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INGREDIENTS AND APPEARANCE
CLARBEN
sodium fluoride gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53045-214 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 10.241 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) FD&C RED NO. 40 (UNII: WZB9127XOA) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) XYLITOL (UNII: VCQ006KQ1E) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) XANTHAN GUM (UNII: TTV12P4NEE) PHOSPHORIC ACID (UNII: E4GA8884NN) HYDROFLUORIC ACID (UNII: RGL5YE86CZ) POLYSORBATE 20 (UNII: 7T1F30V5YH) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53045-214-17 490 g in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date export only 01/01/2016 Labeler - Dharma Research, Inc. (078444642) Registrant - Dharma Research, Inc. (078444642) Establishment Name Address ID/FEI Business Operations Dharma Research, Inc. 078444642 manufacture(53045-214)
