FRESHDENT CAVITY PROTECTION ANTICAVITY- sodium monofluorophosphate paste, dentifrice

FreshDent Cavity Protection Anticavity by

Drug Labeling and Warnings

FreshDent Cavity Protection Anticavity by is a Otc medication manufactured, distributed, or labeled by FreshDent LLC, Swiss Egyptian Co. For Oral Care Products and Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Sodium Monofluorophosphate 0.76% (0.085% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warnings

Keep out of Reach of children

Keep out of 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

Sorbitol, Water, Hydrated Silica, Calcium Carbonate, Sodium Lauryl Sulfate,Carboxymethyl Cellulose, Flavor, Titanium Dioxide, Sodium Saccharin, Sodium Methyl Paraben, FD&C Blue 1.

Questions?

+1-512-653-8814

Package Label

Anticavity Toothpaste

FreshDent          

we care      

Cavity Protection

Strengthens teeth with Active Fluoride

Net Wt. 0.85 oz (24 g)

Distributed by: FreshDent LLC Crockett, TX 75835 www.freshdent.net Made in Egypt

INGREDIENTS AND APPEARANCE

FRESHDENT CAVITY PROTECTION ANTICAVITY 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69338-002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.85 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69338-002-01	1 in 1 CARTON
1		24 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/06/2014

Labeler - FreshDent LLC (079303265)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss Egyptian Co. For Oral Care Products and Cosmetics		366442234	manufacture(69338-002)