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NDC 62839-1151-01 AP-24 Fluoride 8.6 mg/g Details

AP-24 Fluoride 8.6 mg/g

AP-24 Fluoride 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	62839-1151
Product ID	62839-1151_0b506952-b76a-4687-b597-2ba48bed56ff
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 Fluoride
Proprietary Name Suffix	n/a
Non-Proprietary Name	SODIUM MONOFLUOROPHOSPHATE
Product Type	HUMAN OTC DRUG
Dosage Form	PASTE
Route	DENTAL
Active Ingredient Strength	8.6
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 62839-1151-01 (62839115101)

Pricing Information	N/A
NDC Package Code	62839-1151-1
Billing NDC	62839115101
Package	170 g in 1 TUBE (62839-1151-1)
Marketing Start Date	2017-05-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 62d424ae-0d2d-44d5-a1d6-ceb534acc130 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Sodium Monofluorophosphate 0.86% (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 right away.

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 in 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

Dicalcium Phosphate Dihydrate, Water (Aqua), Sorbitol, Glycerin, Dimethicone,1 Poloxamer 338,1 Poloxamer 407,1 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 - 170 g Tube Label

AP24®

Anti-Plaque

Fluoride

Toothpaste

NU SKIN®

170 g e (6 OZ.)

PRINCIPAL DISPLAY PANEL - 170 g Tube Label

INGREDIENTS AND APPEARANCE

AP-24 FLUORIDE

sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62839-1151
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	8.6 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
Water (UNII: 059QF0KO0R)
Sorbitol (UNII: 506T60A25R)
Dimethicone (UNII: 92RU3N3Y1O)
Poloxamer 338 (UNII: F75JV2T505)
Poloxamer 407 (UNII: TUF2IVW3M2)
Glycerin (UNII: PDC6A3C0OX)
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:62839-1151-1	170 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: 5/2017

Document Id: 0b506952-b76a-4687-b597-2ba48bed56ff

Set id: 62d424ae-0d2d-44d5-a1d6-ceb534acc130

Version: 1

Effective Time: 20170510