DR. FRESH DAILIES TRAVEL- sodium fluoride paste

DR. Fresh Dailies Travel by

Drug Labeling and Warnings

DR. Fresh Dailies Travel by is a Otc medication manufactured, distributed, or labeled by Dr. Fresh, Inc., The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

DR. FRESH DAILIES TRAVEL 
sodium fluoride paste

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Dr. Fresh, Inc. (078508990)

Establishment
Name	Address	ID/FEI	Business Operations
The Procter & Gamble Manufacturing Company		007130032	manufacture(64893-210)