AP-24 WHITENING- sodium monofluorophosphate paste

AP-24 Whitening by

Drug Labeling and Warnings

AP-24 Whitening by is a Otc medication manufactured, distributed, or labeled by NSE Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• 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.
• Instruct children under 6 years of age on good brushing and rinsing habits (to minimize swallowing).
• Supervise children as necessary until capable of using without supervision.
• Children under 2 years of age: Consult a dentist or doctor.

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.)

INGREDIENTS AND APPEARANCE

AP-24 WHITENING 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62839-1155
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	7.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62839-1155-1	110 g in 1 TUBE; Type 0: Not a Combination Product	05/08/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	05/08/2017

Labeler - NSE Products, Inc. (803486393)