Label: DOLLAR SHAVE CLUB- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 69522-1111-7 - Packager: Dollar Shave Club
- 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 January 8, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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 per day, or as directed by a dentist or physician.
- Do not swallow.
- Children under 6 years of age: Use a pea-sized amount and supervise until good brushing and rinsing habits are established (to minimize swallowing).
- Children under 2 years of age: Consult a dentist or physician.
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL - 90 g Tube Label
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INGREDIENTS AND APPEARANCE
DOLLAR SHAVE CLUB
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69522-1111 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O) fluoride ion 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength Sorbitol (UNII: 506T60A25R) Hydrated silica (UNII: Y6O7T4G8P9) water (UNII: 059QF0KO0R) Xylitol (UNII: VCQ006KQ1E) Glycerin (UNII: PDC6A3C0OX) Xanthan Gum (UNII: TTV12P4NEE) Titanium Dioxide (UNII: 15FIX9V2JP) Sodium lauryl sulfate (UNII: 368GB5141J) Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876) Product Characteristics Color WHITE Score Shape Size Flavor MINT (Peppermint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69522-1111-7 90 g in 1 TUBE; Type 0: Not a Combination Product 11/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 11/01/2017 Labeler - Dollar Shave Club (004164494) Establishment Name Address ID/FEI Business Operations Lornamead 126440440 MANUFACTURE(69522-1111)