DR. FRESH BRUSH AND COVER- 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 Inc. Brush and Cover Kit

Active Ingredient

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Purpose

Anticavity toothpaste

Uses

Helps protect against cavities

Warnings

If you accidentally swallow more than used for brushing, seek professional assistance or contact a poison control center immediately.

Keep out of the reach of children under 6 years of age.

Directions

Adults and children 6 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician.

Children under 6 years: To minimize swallowing use a pea-sized amount and supervise brushing until good habits are established.

Children under 2 years: Ask a dentist or physician.

Do not swallow.

Inactive Ingredients

Sorbitol, water, hydrated silica, trisodium phosphate, sodium lauryl sulfate, flavor, sodium phosphate, xanthan gum, carbomer 956, sodium saccharin, titanium dioxide, blue no. 1

Comments? Questions?

Dr. Fresh Inc

Buena Park, CA 90620 USA

Toll Free: 1-866-DR-FRESH

Visit us at: www.drfresh.com

Brush and Cover Kit

Dr. Fresh Travel Kit

The Dr. Fresh Travelers brand is expressly made for the consumer who seeks high quality at a reasonable proce. Using innovation in design and intelligence in the manufacturing process, we pride ourselves on products that offer the utmost in value.

Have a great trip!

Dr. Fresh

DR. FRESH BRUSH AND COVER
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64893-481
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.243 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PHOSPHATE ION (UNII: NK08V8K8HR)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64893-481-01	1 in 1 PACKAGE	06/20/2011	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	06/20/2011	01/01/2015

Labeler - Dr. Fresh, LLC (117376803)

Revised: 9/2021

Document Id: 1e042154-78cb-4c35-a60e-c5f8bff8ea2a

Set id: cee8c89a-f3a3-4234-bf87-964739541dc9

Version: 2

Effective Time: 20210927

Dr. Fresh, LLC