Label: SHOPKINS MOUTH WASH- sodium fluoride liquid
- NDC Code(s): 70108-008-01
- Packager: Ashtel Studios Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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Drug Label Information
Updated December 31, 2019
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- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
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INGREDIENTS AND APPEARANCE
SHOPKINS MOUTH WASH
sodium fluoride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70108-008 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.05 mg in 100 g Inactive Ingredients Ingredient Name Strength HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) CITRAL PROPYLENE GLYCOL ACETAL (UNII: 9W7YHX7EX6) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR) WATER (UNII: 059QF0KO0R) .ALPHA.-(.ALPHA.-AMINOPROPYL)BENZYL ALCOHOL HYDROCHLORIDE, ERYTHRO-(+/-)- (UNII: 3IIJ9C722I) GLYCERIN (UNII: PDC6A3C0OX) XYLITOL (UNII: VCQ006KQ1E) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color red (FD & C Red 33) , red (FD &C Red 40) Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70108-008-01 479 g in 1 TUBE; Type 0: Not a Combination Product 10/06/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 10/06/2016 Labeler - Ashtel Studios Inc. (148689180) Establishment Name Address ID/FEI Business Operations Dabur India Limited 650599231 manufacture(70108-008)