Label: SUPERBA- sodium fluoride paste
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Contains inactivated NDC Code(s)
NDC Code(s): 69522-1113-1 - Packager: Dollar Shave Club, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 2, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
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. Do not swallow.
- Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise chldren as necessary until capable of using without supervision.
- Children under 2 years of age: Consult a dentist or a doctor.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUPERBA
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69522-1113 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 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) XYLITOL (UNII: VCQ006KQ1E) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) LINALOOL, (+)- (UNII: F4VNO44C09) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) XANTHAN GUM (UNII: TTV12P4NEE) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) LIMONENE, (+)- (UNII: GFD7C86Q1W) Product Characteristics Color Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69522-1113-1 142 g in 1 TUBE; Type 0: Not a Combination Product 10/11/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 10/11/2021 Labeler - Dollar Shave Club, Inc. (004164494)