AP-24 WHITENING- sodium monofluorophosphate paste 
NSE Products, Inc.

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.

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AP-24® Whitening Toothpaste

Drug Facts

Active Ingredients

Sodium Monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Purpose

anticavity

Use

Aids in the prevention of dental cavities.

Warning

  • Keep out of the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Inactive Ingredients

Water (Aqua), Hydrated Silica, Sorbitol, Alumina, Glycerin, Tetrasodium Pyrophosphate, PEG-12, Dimethicone1, Poloxamer 3381, Poloxamer 4071, Cellulose Gum, Sodium Lauryl Sulfate, Flavor (Aroma), Sodium Saccharin, Titanium Dioxide (CI 77891).


1
AP-24,® the patented ultra-emulsion of medical grade, high molecular weight Dimethicone and the surfactants Poloxamer 338 and Poloxamer 407, helps to remove plaque during brushing and helps reduce plaque buildup.

Questions

1-888-742-7626

PRINCIPAL DISPLAY PANEL - 110 g Tube Label

AP24®

Whitening
Fluoride
Toothpaste

NU SKIN®

110 g e (4 oz.)

PRINCIPAL DISPLAY PANEL - 110 g Tube Label
AP-24 WHITENING 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62839-1155
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion7.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Sorbitol (UNII: 506T60A25R)  
Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
Glycerin (UNII: PDC6A3C0OX)  
Sodium Pyrophosphate (UNII: O352864B8Z)  
Polyethylene Glycol 600 (UNII: NL4J9F21N9)  
Dimethicone (UNII: 92RU3N3Y1O)  
Poloxamer 338 (UNII: F75JV2T505)  
Poloxamer 407 (UNII: TUF2IVW3M2)  
Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62839-1155-1110 g in 1 TUBE; Type 0: Not a Combination Product05/08/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35505/08/2017
Labeler - NSE Products, Inc. (803486393)

Revised: 10/2017
Document Id: e2651a88-0bd4-475b-bf7e-79d267c75ea0
Set id: 57e9e68c-41dd-470b-80db-dfaedc0e2a0a
Version: 2
Effective Time: 20171020
 
NSE Products, Inc.