DR. FRESH DAILIES TRAVEL- sodium fluoride paste
Dr. Fresh, 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.

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DR. Fresh Dailies Travel Kit

Drug Facts

Active Ingredient

Sodium fluoride 0.243 percent (0.15 percent w v fluoride ion)

Purpose

Anticavity Toothpaste

Use:

aids in the prevention of dental cavities

Warnings

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.
Children under the age of 6:	Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
Children under 2 years of age:	Ask a dentist or doctor

Inactive Ingredients:

Aloe Vera Extract, Carbomer, Fragrance, Glycerin, Isopropyl Myristate, Propylene Glycol, Titanium Dioxide, Triethanolamine, Vitamin E, Water

Questions or Comments

Toll Free: 1-866-DR-Fresh (1-866-373-7374) or comments drfresh.com

Visit us online at: www.drfresh.com

Monday-Friday 8:30 am to 5:30 pm

Package Labeling:

DR. FRESH DAILIES TRAVEL
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64893-210
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64893-210-00	1 in 1 KIT	07/16/2010	01/01/2015
1		24 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	07/16/2010	01/01/2015

Labeler - Dr. Fresh, LLC (117376803)

Revised: 9/2021

Document Id: 17f2a5f3-c63a-456e-b306-98e22ac76cb0

Set id: e1dce364-e7df-41ac-afe5-7cbb08fec022

Version: 4

Effective Time: 20210927

Dr. Fresh, LLC