Search by Drug Name or NDC

NDC 62839-1152-01 AP-24 0.2 mg/mL Details

AP-24 0.2 mg/mL

AP-24 is a ORAL MOUTHWASH in the HUMAN OTC DRUG category. It is labeled and distributed by NSE Products, Inc.. The primary component is SODIUM FLUORIDE.

MedlinePlus Drug Summary

Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 62839-1152-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fluoride

Product Information

NDC	62839-1152
Product ID	62839-1152_84e1d4d6-745e-4bf1-b196-1bdf9f07a3ca
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
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sodium Fluoride
Product Type	HUMAN OTC DRUG
Dosage Form	MOUTHWASH
Route	ORAL
Active Ingredient Strength	0.2
Active Ingredient Units	mg/mL
Substance Name	SODIUM FLUORIDE
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 62839-1152-01 (62839115201)

Pricing Information	N/A
NDC Package Code	62839-1152-1
Billing NDC	62839115201
Package	500 mL in 1 BOTTLE (62839-1152-1)
Marketing Start Date	2017-05-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c6f9b823-1ed7-42a2-9714-b46b7f63da73 Details

SPL UNCLASSIFIED SECTION

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

Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste.
Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out.
Do not swallow the rinse.
Do not eat or drink for 30 minutes after rinsing.
Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
Supervise children as necessary until capable of using without supervision.
Children under 6 years of age: Consult a dentist or doctor.

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

INGREDIENTS AND APPEARANCE

AP-24

sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62839-1152
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	0.2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62839-1152-1	500 mL in 1 BOTTLE; 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: 84e1d4d6-745e-4bf1-b196-1bdf9f07a3ca

Set id: c6f9b823-1ed7-42a2-9714-b46b7f63da73

Version: 1

Effective Time: 20170510