AP-24- sodium fluoride mouthwash

AP-24 by

Drug Labeling and Warnings

AP-24 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 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.)

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62839-1152-1	500 mL in 1 BOTTLE; 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)