FRESHDENT KIDS STRAWBERRY ANTICAVITY TOOTH- sodium fluoride paste, dentifrice

FreshDent Kids Strawberry Anticavity Tooth by

Drug Labeling and Warnings

FreshDent Kids Strawberry Anticavity Tooth 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 Fluoride 0.188% (0.065% w/v fluoride ion)

Purpose

Anticavity

Use

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, Glycerin, Water,Silica, Carboxymethyl Cellulose, Lauryl Sulfate, Sodium Saccharin, Diazolidinyl Urea, Strawberry Flavor, Menthol, D &C Red No. 33.

Questions?

+1-512-653-8814

Package Label

Strawberry Anticavity toothpaste

FreshDent           Kids

we care

Net Wt. 0.85 oz (24 g)

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

INGREDIENTS AND APPEARANCE

FRESHDENT KIDS STRAWBERRY ANTICAVITY TOOTH 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69338-001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.65 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)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
MENTHOL (UNII: L7T10EIP3A)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69338-001-01	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(69338-001)