Label: HELLO MAGICAL MERMAID- sodium fluoride gel, dentifrice
- NDC Code(s): 35000-680-10
- Packager: Colgate-Palmolive Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
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 Label
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INGREDIENTS AND APPEARANCE
HELLO MAGICAL MERMAID
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-680 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 GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM BICARBONATE (UNII: 8MDF5V39QO) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) POTASSIUM CITRATE (UNII: EE90ONI6FF) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) REBAUDIOSIDE A (UNII: B3FUD0528F) Product Characteristics Color Score Shape Size Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35000-680-10 119 g in 1 TUBE; Type 0: Not a Combination Product 07/01/2023 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)