Label: HELLO UNICORN SPARKLE- sodium fluoride gel, dentifrice
- NDC Code(s): 35000-686-10
- Packager: Colgate-Palmolive Company
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 19, 2024
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- 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 physician children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician - Inactive ingredients
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 119 g Tube Carton
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INGREDIENTS AND APPEARANCE
HELLO UNICORN SPARKLE
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-686 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.1 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) XYLITOL (UNII: VCQ006KQ1E) XANTHAN GUM (UNII: TTV12P4NEE) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35000-686-10 1 in 1 CARTON 07/01/2023 1 119 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 07/01/2023 Labeler - Colgate-Palmolive Company (001344381)