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FreshDent Kids Strawberry Anticavity Tooth

Dosage form: paste, dentifrice
Ingredients: SODIUM FLUORIDE 0.65mg in 1g
Labeler: FreshDent LLC
NDC Code: 69338-001

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.

FreshDent Kids Strawberry Anticavity Toothpaste

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

FRESHDENT KIDS STRAWBERRY ANTICAVITY TOOTH 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69338-001
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.65 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
GLYCERIN 
WATER 
SILICON DIOXIDE 
CARBOXYMETHYLCELLULOSE 
SODIUM LAURYL SULFATE 
SACCHARIN SODIUM 
DIAZOLIDINYL UREA 
MENTHOL 
D&C RED NO. 33 
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69338-001-011 TUBE in 1 CARTON
124 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/06/2014
Labeler - FreshDent LLC (079303265)
Establishment
NameAddressID/FEIOperations
Swiss Egyptian Co. For Oral Care Products and Cosmetics366442234manufacture(69338-001)

Revised: 11/2014
 
FreshDent LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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