ADVANCED FLUORIDE ANTICAVITY: Package Insert and Label Information

ADVANCED FLUORIDE ANTICAVITY- sodium monofluorophosphate paste, dentifrice
Personal Care Products, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient Drug Facts

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity toothpaste

Use

Aids in the prevention of cavities

Warnings

If more than is used for brushing is accidentally swallowed get medical help or contact a poison control center right away.

Keep out of reach of children

Keep out of reach of children under 6 yrs of age.

Directions

adults and children 2 years. and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist.

do not swallow

to minimize swallowing, use a pea-sized amount in children under 6 years old

supervise children’s brushing until good habits are established

children under 2y ears: ask a dentist before use.

inactive ingredients

calcium carbonate, calcium hydrogen phosphate, carboxymethyl cellulose, flavor, glycerin, hydrated alumina, hydrated silica, potassium sorbate, saccharin sodium, sodium lauryl sulfate, sorbitan monooleate, sorbitol, titanium dioxide, water, xanthan gum.

ADVANCED FLUORIDE ANTICAVITY product label

CAVITY FIGHTING TOOTHPASTE

Distributed by:

Personal Care Products, LLC

Bingham Farms, MI 48025-2463

Made in China

Advanced Fluoride Anticavity Toothpaste

New Ultra Breath Freshener Stripe

Net Wt 6.4oz (181g)

Multi
Protection

Fights Cavities

Freshens Breath

ADVANCED FLUORIDE ANTICAVITY sodium monofluorophosphate paste, dentifrice

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:29500-9181 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION 1000 mg in 181 g

Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE ANHYDROUS DIBASIC CALCIUM PHOSPHATE POWDERED CELLULOSE GLYCERIN ALUMINUM OXIDE HYDRATED SILICA POTASSIUM SORBATE SACCHARIN SODIUM SODIUM LAURYL SULFATE SORBITAN MONOOLEATE SORBITOL TITANIUM DIOXIDE WATER XANTHAN GUM FD&C BLUE NO. 1

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:29500-9181-6 1 TUBE in 1 PACKAGE contains a TUBE 1 181 g in 1 TUBE This package is contained within the PACKAGE (29500-9181-6)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 07/24/2017

Labeler — Personal Care Products, LLC (966155082)

Registrant — Personal Care Products, LLC (966155082)

Revised: 08/2017 Personal Care Products, LLC