AP-24- sodium fluoride mouthwash 
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® Mouthwash

Drug Facts

Active Ingredient

Sodium Fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

anticavity

Use

Aids in the prevention of dental cavities.

Warning

  • Keep out of the reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Do not use if saftey seal is broken.

Directions

Inactive Ingredients

Water (Aqua), Sorbitol, Glycerin, Poloxamer 338,1 Poloxamer 407,1 Dimethicone,1 Sodium Phosphate, Phosphoric Acid, Disodium EDTA, Sodium Saccharin, Sodium Benzoate, Flavor (Aroma).


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 and helps reduce plaque buildup.

Questions?

1-888-742-7626

PRINCIPAL DISPLAY PANEL - 500 ml Bottle Label

AP24®

Anti-Plaque
Fluoride
Mouthwash

NU SKIN®

500 ml e (16.9 Fl. Oz.)

PRINCIPAL DISPLAY PANEL - 500 ml Bottle Label
AP-24 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62839-1152
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Sorbitol (UNII: 506T60A25R)  
Glycerin (UNII: PDC6A3C0OX)  
Poloxamer 338 (UNII: F75JV2T505)  
Poloxamer 407 (UNII: TUF2IVW3M2)  
Dimethicone (UNII: 92RU3N3Y1O)  
Sodium Phosphate (UNII: SE337SVY37)  
Phosphoric Acid (UNII: E4GA8884NN)  
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62839-1152-1500 mL in 1 BOTTLE; 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: 5/2017
Document Id: 84e1d4d6-745e-4bf1-b196-1bdf9f07a3ca
Set id: c6f9b823-1ed7-42a2-9714-b46b7f63da73
Version: 1
Effective Time: 20170510
 
NSE Products, Inc.