Label: REMBRANDT DEEPLY WHITE PLUS PEROXIDE WHITENING FRESH MINT- sodium monofluorophosphate paste, dentifrice
- NDC Code(s): 42002-617-01
- Packager: Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, 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.
Updated March 16, 2012
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- SPL UNCLASSIFIED SECTION
- Active ingredient
Sodium Monofluorophosphate 0.884% w/w (0.0.15% w/v fluoride)Close
aids in the prevention of dental cavitiesClose
- Keep out of reach of children under 12 years of age.
- If more than used brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
- Adults and children 12 years of age and older:
- brush teeth thoroughly, preferably after each meal or at least 2 times a day, or as directed by a dentist or physician
- supervise children as necessary until capable of using without supervision
- children under 12 years of age: ask a dentist or doctor
- Other information
- store at 20° - 25°C (68° – 77° F)
- Inactive ingredients
glycerin, hydrated silica, urea peroxide, aluminum hydroxide, modified food starch, flavor, sodium citrate, propylene glycol, cocamidopropyl betaine, papain, sodium lauryl sulfate, carbomer, sodium saccharin, calcium disodium EDTAClose
- Questions or comments?
- SPL UNCLASSIFIED SECTION
Distributed by: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc., Skillman, NJ 08558-9418Close
- PRINCIPAL DISPLAY PANEL - 74 g Tube Carton
PEROXIDE TOOTHPASTE FORMULATED FOR SUPERIOR WHITENING
Whitens Deeper* & Restores Enamel
NET WT 2.6 oz (74g)
- INGREDIENTS AND APPEARANCE
REMBRANDT DEEPLY WHITE PLUS PEROXIDE WHITENING FRESH MINT
sodium monofluorophosphate paste, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42002-617 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Sodium Monofluorophosphate 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength Glycerin (UNII: PDC6A3C0OX) Hydrated silica (UNII: Y6O7T4G8P9) Carbamide Peroxide (UNII: 31PZ2VAU81) Aluminum Hydroxide (UNII: 5QB0T2IUN0) Sodium Citrate (UNII: 1Q73Q2JULR) Propylene Glycol (UNII: 6DC9Q167V3) Cocamidopropyl Betaine (UNII: 5OCF3O11KX) Papain (UNII: A236A06Y32) Sodium Lauryl Sulfate (UNII: 368GB5141J) Saccharin Sodium Dihydrate (UNII: SB8ZUX40TY) Edetate Calcium Disodium Anhydrous (UNII: 8U5D034955) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42002-617-01 1 in 1 CARTON 1 74 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 03/16/2012 Labeler - Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. (831417154)