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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 |
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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)
NDC Package Code | 62839-1151-1 |
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Billing NDC | 62839115101 |
Package | 170 g in 1 TUBE (62839-1151-1) |
Marketing Start Date | 2017-05-08 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 62d424ae-0d2d-44d5-a1d6-ceb534acc130 Details
Warning
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.
PRINCIPAL DISPLAY PANEL - 170 g Tube Label
INGREDIENTS AND APPEARANCE
AP-24 FLUORIDE
sodium monofluorophosphate paste |
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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