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NDC 62839-1155-01 AP-24 Whitening 7.6 mg/g Details

AP-24 Whitening 7.6 mg/g

AP-24 Whitening is a DENTAL PASTE in the HUMAN OTC DRUG category. It is labeled and distributed by NSE Products, Inc.. The primary component is SODIUM MONOFLUOROPHOSPHATE.

Product Information

NDC	62839-1155
Product ID	62839-1155_e2651a88-0bd4-475b-bf7e-79d267c75ea0
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	AP-24 Whitening
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sodium Monofluorophosphate
Product Type	HUMAN OTC DRUG
Dosage Form	PASTE
Route	DENTAL
Active Ingredient Strength	7.6
Active Ingredient Units	mg/g
Substance Name	SODIUM MONOFLUOROPHOSPHATE
Labeler Name	NSE Products, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part355
Listing Certified Through	2024-12-31

Package

Package Images

NDC 62839-1155-01 (62839115501)

Pricing Information	N/A
NDC Package Code	62839-1155-1
Billing NDC	62839115501
Package	110 g in 1 TUBE (62839-1155-1)
Marketing Start Date	2017-05-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 57e9e68c-41dd-470b-80db-dfaedc0e2a0a Details

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.)

PRINCIPAL DISPLAY PANEL - 110 g Tube Label

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62839-1155-1	110 g in 1 TUBE; Type 0: Not a Combination Product	05/08/2017

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

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